FDA Investigator Helen B Ricalde

Helen B Ricalde has conducted inspections on 230 sites in 22 countries as of 11 Oct 2023. See below for a list of the FDA enforcement documents resulting from those inspections.

Investigator Details

Number of Inspected Sites:
230
Last Inspection Date:
11 Oct 2023
Investigator Role:
FDA Investigator
Redica ID:
Countries of Inspections:
Germany, Spain, United States of America, France, Italy, Sweden, United Kingdom of Great Britain and Northern Ireland, Norway, Canada, Belgium, Korea (Republic of), Netherlands, Singapore, Austria, Denmark, Peru, India, Switzerland, Mexico, Malta, Australia, Ireland
FDA Investigators that have inspected at least one site in common with Helen B Ricalde:
Adam R Cooke, Addam S Reynolds, Ademola O Daramola, Adetutu M Gidado, Aditi S Thakur, Akbar J Zaidi, Albert M Brindle, Alberto A Viciedo, Alexey Khrenov, PhD, Ali A Patino, Alice C Silva, Alice S Tsao, Alicia Gilbert, Alicia M Mozzachio, Alla Kachko, PhD, Allen Lou, Alois P Provost, Althea A Williams, Amanda B Athey, Amanda Dinaro, Amanda S Zorn, Amber D Brodas, Amir Alavi, Amy A Johnson, Amy Johnson, Amy Kim, Amy L Singer, Amy M Codella, Amy M Cramer, Amy Wyan Mai, Ana P Barido, Ana S Cabrera, Anastasia G Lolas, Anastasia I Offordile, Andrea D Swingle, Andrew C Chang, Andrew M Abramowitz, Andria L Kuhlman, Angela E Glenn, Angela Jourdain, Angela K Shen, Anissa M Cheung, Anissa M Vargas, Anita Narula, PhD, Anita R Michael, Ankur C Patel, Ann L Demarco, Ann Marie Montemurro, Ann Marie Schofield, Anna Flynn, Anna M Alexander, Anna R Kwilas, Annemarie Bodnar, Annette A Ragosta, Anthony C Warchut, Anthony J Donato, Anthony M Criscuolo, Jr, Anthony N Onianwa, Antonina Aydanian, Arduino Frankovic, Arie C Menachem, Arthur G Hurst, Arthur S Williams, Jr, Ashley J Burns, Ashley N Queen, PhD, Asia D Clark, Atul J Agrawal, Audrey Thereset Uy, Ava M Bowman, Azza Talaat, Barbara A Gullick, Barbara A Rusin, Barbara J Maulfair, Barbara Jwilimczyk Macri, Barbara L Rellahan, PhD, Barbara M Frazier, Barbara T Carmichael, Benjamin J Smith, Benton M Ketron, Bijoy Panicker, Binh T Nguyen, Bo Chi, PhD, Bonita S Chester, Bradley Dworak, PhD, Brandi N Mcgrady, Brandon C Heitmeier, Brandon L Mariner, Brandy N Lepage, Brenda S Zimmer, PhD, Brentley S Collins, Brian D Nicholson, Brian J Ryan, Brian M Campbell, Brian S Keefer, Brittany M Lowe, Brooke K Higgins, Bruce H Mccullough, Burnell M Henry, Byungja E Marciante, Calvin B Koerner, Cara M Minelli, Carl A Anderson, Carl A Huffman, III, Carl E Lovrich, Carl Lee, Carla J Lundi, Carrie A Hughes, Carrie Ann Plucinski, Caryn M Mcnab, Cassandra L Abellard, Catherine V Quinlan, Cathleen A Carr Sharpe, CDR Donald Ertel, CDR Jeremy L Wally, PhD, CDR Kimberly Y Martin, CDR Rochelle B Young, RPh, MSA, CDR Sean T Creighton, CDR Thomas R Berry, PPh, Chad E Schmear, Chad R Burger, Chao Ming Tsai, Charanjeet Jassal, Charisse K Green, Charles D Boison, Charles I Ann, Charles Jewell, Charles M Edwards, Charles M Spyr, Charlotte P Chang, Cheng H Yen, Cheryl A Clausen, Chiang Syin, PhD, Christian D Lynch (CDL), Christina H Owens, Christina J Sauder, PhD, Christina N Maurino, Christina V Santos, Christine A Harman, PhD, Christine M Cerenzio, Christopher J Adams, Christopher R Czajka, Concepcion Cruz, Jr, Constantin Y Philopoulos, Corrine M Carter, Craig D Zagata, Craig W Swanson, Creighton T Tuzon, Cynthia Jim, CSO, Cynthia L Kelley, Danial S Hutchison, Daniel C Kearns, Daniel J Brown, Daniel J Gorski, Daniel J Grabicki, Daniel Kearns, Daniel L Zheng, Daniel Lagasse, Darla J Christopher, Darren S Morgan, Daryl A Dewoskin, Dave Hafner, David A Paterson, David G Whitman, David H Smith, David J Gasparovich, David J Hafner, David L Chon, David M Beltran, Dawn C Olenjack, Dawn L Wydner, Deborah B Goffman, Deborah B Nixon, Deborah J Parris, Deborah M Trout, Debra I Love, Debra J Bennett, Debra L Pagano, Debra Lboyd Seale, Decarlos A Gomez, Demitria J Argiropoulos, Demitria J Xiradakis, Denise M Digiulio, Denise M Visco, Investigator, Dennis Cantellops Paite, Dennis E Guilfoyle, PhD, Derek C Price, Destry M Sillivan, Devaughn Edwards, Dhaval H Patel, Diane C Thibodeau, Diane L Raccasi, Diane M Gubernot, Dino A Fiegelstock, Djamila Harouaka, Dmitriy V Volokhov, PhD, Doan T Nguyen, PharmD, Dolores Harper, Don H Bark, PhD, Donald C Obenhuber, PhD, Dongping Dai, PhD, Donna Ltartaglino Besone, Dorothy J Denes, Dorothy W Lee, Douglas A Campbell, Douglas C Kovacs, Dr. Barbara D Paul, PhD, Dr. Gang Wang, PhD, Dr. Guang Gao, PhD, Dr. Ralph M Bernstein, PhD, Dr. Robert C Horan, MD, Dr. Willie F Vann, PhD, Dr. Zhihao Qiu (Peter), PhD, Dr. Zhou Chen (nmi), MD PhD, Dung N Tran, Dwayne E Dollins, Edmund F Mrak, Jr, Eileen A Liu, Eliezar Ramos, Elizabeth A Laudig, Ellen Huang, Ellen P Madigan, Elliot P Cowam, PhD, Elmina E Akwo, Emest F Bizjak, Emily A Walters, Emily B Camire, Emily J Orban, Emmanuel A Dimaano, Jr, Emmanuel Jramos Maldonado, Enrico Joset Mangahis, Eric C Schmitt, Eric J Cunningham, Eric M Mueller, PharmD, Eric Rothschild, Erika E Englund, PhD, Erin D Mccaffery, Erin L Nagel, Erma Zaimova, Esteban Beltran, Esther C Broner, PhD, Eural E Porter, Felix Maldonado, Frank J Marciniak, Frank Verni, Frederick F Razzaghi, Freyja V Lynn, Fulton A Varner, Gail L Katz, Garrad R Poole, Gary J Lehr, Gary T Greco, Gene D Arcy, Geneve M Maxwell, Geneve M Parks, George J Flynn, George Pyramides, Gerald B Seaborn, Jr, Gerald Mierle, Geraldine D Sanders, Gianine E Delade, Gianine E Tompkins, Gifford Whitehurst, Jr, Ginger M Sykes, Grace Deneke, Grace I Cortesini, Gregson A Joseph, Guerlain Ulysse, Gunther Boekhoudt, PhD, Gwyn G Dickinson, Hala L Selby, Haley H Seymour, Hans T Meyers, Harry J Brewer, Haruhiko Murata, Helen R Bester, Helen Verdel, Heriberto Negron Rivera, Holly M Scott, Humera T Khan, Hung H Do, MS, Hyesuk Kong, Ifueko Osemwota, Iram R Hassan, PhD, Ivis L Negron, J David Doleski, Jacob G Lutz, Jacqueline Mdiaz Albertini, Jacqueline S Warner, James A Beaulieu, James A Lane, James A Liubicich, James C Lee, PharmD, James C Maclaughlin, James D Bridges, James D Planchon, James E Keller, PhD, James K Ireland, James L Dunnie, Jr, James L Kenney, DSc, James M Mason, James M Simpson, James Norman, James P Mcevoy, James P Stumpff, James R Evans, James T Mccoy, James W Leonette, James W Plucinski, James W Whitney, Jan B Welch, Janet A Rajan, Janet L Bowen, Janete F Guardia, Jason F Chancey, Jay Slater, MD, Jay T Wong, Jazmine N Brown, Jean M Kelahan, Jeanne M Morris, Jeffrey A Sincek, Jeffrey A Sommers, Jeffrey D Meng, Jeffrey J Ebersole, Jeffrey M Watson, Jeffrey P Raimondi, Jennifer A Baker, Jennifer A Bazergui, Jennifer L Bridgewater, Jennifer L Custodio, Jennifer L Schmidt, Jennifer L Sheehan, Jennifer M Gogley, Jennifer Macmillan, Jeremy W Rotton, Jesse A Vazquez, Jessica Hankins, PhD, Jessica S Estriplet, Joan A Loreng, Joan Adamo, Joanne E King, Joanne M Hajoway, Joanne Pryzbylik, Jocelyn C Turner, Joey C West, Joey V Quitania, Jogy George, John A Podsadowski, John D Mcintosh, John Dan, John F Cipollo, John M Mcinnis, John P Mistler, Johnna L Bleem, Jonah S Ufferfilge, Jonathan Ho, Jonee J Mearns, Jose A Lopez, Jose Acruz Gonzalez, José E Meléndez, Jose M Cayuela, Jose M Melendez, Jose Ohernandez Guzman, Jose R Hernandez, Joseph A Morkunas, Joseph F Mcginnis, RPh, Joseph George, Joseph H Procopio, Jr, Joseph J Vannelli, Joseph L Despins, PhD, Joseph Milcetic, Josh Renzo N Ramilo, Joshua J Silvestri, Joy Rkozlowski Klena, Joyce A Rockwell, Juanita P Versace, Jude C Dikes, Judith A Jankowski, Julianne C Mccullough, Julie D Bringger, Junho Pak, Justin A Boyd, Justine M Corson, Justine Tomasso, Kalavati Suvarna, PhD, Karen A Coleman, Karen E D'orazio, Karen Emasley Joseph, Karen L Kosar, Karen M Cooper, Karl D Hezel, Karyn M Campbell, Katherine E Jacobitz, Kathleen B Mihalik, Kathleen B Swat, Kathleen R Jones, PhD, Kathryn A Nagy, Kathryn Carbone, MD, Kathryn G Brown, Kazi Rafiquzzaman, Keith M Reilly, Keith Wonnacott, PhD, Kelli F Dobilas, Kelli Regente, Kellie Leveille, Kelly D Moore, Kelly Doremus, Kelly I Anderson, Kelly N Kerr, Kelvin Cheung, Kenneth H Williams, Kenneth L Smalls, Kenneth M Gordon, Kent C Faul, Kerry A Kurdilla, Kerun Hardeo, Kevin A Gonzalez, Kevin D Kallander, Kevin Obrien, Kevin P Foley, Kham Phommachanh, Kim Lthomas Cruse, Kim M Downing, Kimberly L Schultz, Kimberly Lewandowski Walker, Kimberly M Bigler, Kimberly M White, Kinh Q Mac, Kip J Hanks, Kirsten L Vadheim, PhD, Kish Bolden, Ko U Min, Kristen D Evans, Kristina J Donohue, Kristina L Conroy, Kristy A Zielny, Kujtim Sadiku, Kula N Jha, L Gnnmassimia Massimilla, PharmD, Laishan L Lam, Lakisha M Williams, Larry K Austin, Lata C Mathew, PhD, Laura Fontan, MS, Laurel A Beer, Lauren L Vajo, Laurie A Haxel, Laurie B Frazier, Laurie P Norwood, Laurimer Kuilan Torres, Lawrence J Stringer, Lawrence R Johnson, Lawrence W Farina, LCDR Chad N Thompson, LCDR Debra Emerson, LCDR Margaret Edi Gennaro, LCDR Randall L Morris, Leena Thomas, Leigh Anne Myers, Leiyun Boone, PhD, Leonard H Lavi, Lequita M Mayhew, Lesley Maep Lutao, Leslie A Paul, Leslie D Wagner, Lestine C Webb, Lewis K Antwi, Li Li, Liatte Kreuger, PharmD, Linda L Green, Linda M Cheny, Linda M Sacco, Linda R Kuchenthal, Linda S Mattingly, Linda Thai, Lindsey Brown, PhD, Lindsey M Schwierjohann, Lisa B Hall, Lisa B Orr, Lisa Harlan, Lisa Hornback, Lisa L Flores, Lisa M Bellows, Lisa M Feola, Lisa M Parsons, Lisa Mathew, Lisa P Oakes, Logan T Williams, Lorelei S Jarrell, Loretta Nemchik, Lori A Carr, Lori Peters, Lori S Lawless, Lorraine L Chavis, Louis G An, LT John M Mastalski, Lucas B Leake, Luella J Rossi, Luis Mburgos Medero, Lura D Baquero, Lydia I Rosas Marty, Maan S Abduldayem, Madelyn Renteria, Maira P Brading, Malgorzata G Norton, PhD, Manhar R Patel, Marc A Jackson, Jr, Marc S Neubauer, Marcellinus D Dordunoo, Marcelo O Mangalindan, Jr, Marcia D Fields, Marcus F Yambot, Marea K Harmon, Margaret E Sarles, Margaret L Bolte, Margaret M Annes, Margaret M Sands, Margaret Torres Vazquez, Maria Estrella, Maria Joselopez Barragan, PhD, Marian E Major, PhD, Marianne Allen, Marie B Buen Bigornia, Marie Elena C Puleo, Marie F Morin, Marion Michaelis, Mariza M Jafary, Marjorie A Shapiro, PhD, Marjorie D Schultz, Mark R Mcclain, Marla A Cassidy, Marsha W Major, Martha Sullivan Myrick, Martha T Olone, Marvin D Jones, Mary Davis Lopez, Mary P Padgett, Mary T Carden, Maryna C Eichelberger, PhD, Mate Tolnay, Matthew A Spataro, Matthew D Schnittker, Matthew J Gretkierewicz, Matthew W Kyle, Maureen C Melvin, Maxwell Van Tassell, PhD, Maya M Davis, Megan A Haggerty, Meghan L Fetterly, Meghan L Vanhouse, Meihong Liu, Meisha R Sampson, Meisha Waters, Melba Trivera Clavell, Melissa A Zuppe, Melissa B Libby, Melissa J Garcia, Melissa T Roy, Mercy O Quagraine, Meyer J Slobotsky, Michael A Charles, Michael A Moses, PhD, Michael Curbarg, Michael D Robinson, Michael E Maselli, Michael F Skelly, PhD, Michael Gurbarg, Michael J Verdi, Michael L Casner, Michael L Chasey, Michael Levin, Michael R Dominick, Michael R Goga, Michael R Klapal, Michael Serrano, Michael Shanks, MS, Michael T Cyrus, Michael W Burd, Michele Gottshall, Michele L Forster, PhD, Michele L Glendenning, Michele L Obert, Michele Perry Williams, Michelle A Marsh, Michelle J Glembin, Miguel A Martinez Perez, Miguel Gmanzano Maldonado, Mihaly S Ligmond, Mikhail V Ovanesov, PhD, Milan S Blake, Mindy M Chou, Minh D Phan, Mizanne E Lewis, Mohammad Heidaran, PhD, Monica E Murie, Monica J Wilkins, Mra Davism, Mra M Barbosar, Mra Mcculloughj, Mra Munizn, Muralidhara B Gavini, PhD, Myra K Casey, Naakesh N Gomanie, Nadeem I Chaudhry, Nancy E Kirschbaum, Nancy F Scheraga, Nancy G Schmidt, Nancy L Meade, Nancy L Neiger, Nancy L Rolli, Nancy T Waites, Nariman Patenaude, Natalya M Ananyeva, Nawab A Siddiqui, Nayan J Patel, Nazmul Hassan, Nealie C Newberger, Nerizza B Guerin, Nicholas A Violand, Nicholas C Mendiola, Nicholas F Lyons, Nicholas M Smith, Nicole J Clausen, Nicole K Trudel, Nicole S Williams, Niketa Patel, Nikisha M Bolden, Nikki S Ramirez, Nimmy Mathews, Nina Yang, Niraj R Mehta, PhD, Nisha C Patel, Nobuko H Katagiri, Norman Wong, Normica G Facey, Olga Simakova, PhD, Omotunde O Osunsanmi, Oumou Barry, Pankaj H Amin, Parul M Patel, Patricia A Morrow, Patricia D Stahnke, Patricia F Hudson, Patricia F Hughes, PhD, Patricia H Dlugosz, Patrick C Klotzbuecher, Patrick L Wisor, Patsy J Domingo, Paul A Bonneau, Paul E Stein, Paul L Bellamy, Paul M Chefor, Paul Mouris, Paul W Moy, Paula A Trost, Paula J Bretz, Peng Zhou, Perry T Nichols, Peter Abel, Peter E Baker, Peter R Lenahan, Philip A Klimkewicz, Philip F Istafanos, DMV, MS, Phillip M Pontikos, Prabhu P Raju, Priscilla M Pastrana, Qiao Y Bobo, Qing Joanna Zhou, PhD, Rafael E Arroyo, Rafael Padilla, Rafeeq A Habeeb, Rajiv R Srivastava, Ralph A Erickson, Ralph Jerndal, Ramesh Potla, PhD, Ramon A Hernandez, Ramon E Martinez, Randa Melhem, PhD, Randy L Self, Raphael E Brykman, Raquel Gonzalez Rivera, Raymond R Roy, PhD, Raymond W Brullo, Reba A Gates, Rebecca E Dombrowski, Rebecca K Olin, Rebecca Rodriguez, Regina Gibson Melton, Regina T Brown, Reginald D Neal, Remache, Reyes Candau Chacon, PhD, Richard D Manney, Richard Heath Coats, Richard Jay Tucker, RS, Richard K Vogel, Richard Ledwidge (nmi), PhD, Richard T Riggie, Richard W Thornton, Richmond K Yip, Riley C Myers, PhD, Robert B Shibuya, MD, Robert C Coleman, Robert C Steyert, Robert D Tollefsen, Robert E Moncayo, Robert G Ruff, Robert J Ham, Robert J Martin, Robert Jennings, Robert L Stevenson, Robert M Barbosa, Robert R Barbosa, Robert Sausville, Robert Sharpnack, Roberta W Cunningham, Robin Levis, PhD, Robin P Mathew, Rochelle K Kimmel, Rodney D Combs, Roger F Zabinski, Roger J Adams, Roman T Drews, PhD, Rona A Leblanc, PhD, Ronald G Crawford, Ronald T Nowalk, Ronnie E Jackson, Rory K Geyer, Rosa J Motta, Rose Ashley, Rose Xu, Ruben C Quintana, Russ E Davis, Russell J Glapion, Russell K Riley, Ruth A Williams, Ruth Moore, PhD, S Lori Brown, PhD MPH, Sachinkumar V Patel, Saied A Asbagh, Saleem A Akhtar, Samantha J Bradley, Samina S Khan, Samuel K Gibbons, Jr, Samuel T Walker, Sandra A Hughes, Sandra D Thompson, Sandra Kershaw, Sangeeta M Khurana, PhD, Sanket N Patel, Santiago Gallardo Johnson, Sarah A Meehan, Sarah Adella Fave, Sarah B Tanksley, Sarah E Rhoades, Sarah Forney, Sarah M Meng, Sarah M Napier, Sarah Rhoades, Sasha M Latonis, Satheesh Thomas, Scott A Golladay, Scott E Norris, Scott T Ballard, Seema S Singh, Sergey S Akimov, Shafiq S Ahadi, Shari L Kahn, Sharmila Shrestha, Sharon K Thoma, PharmD, Sheila Dreher Lesnick, Shelley H Beausoleil, Sherri J Liu, Sherry L Secrist, BLT DO, Sheryl A Kochman, Shirley H Isbill, Shirley S Wen, Shuang Tang, Shwnji Susie Lee, Sidney B Priesmeyer, Simone E Pitts, Sina Shojaee, Sinai I Davis, Sixto M Mercado Rios, Solomon Yimam (SY), Sony Mathews, Srinivas R Chennamaneni, PhD, Sripal R Mada, PhD, Stacey S Degarmo, Stella Yuen, Stephanie A Slater, MS, Stephanie Mangigian, MS/OSH, RN, Stephen C Smith, Stephen D Brown, Stephen D Eich, Stephen J Mottola, Stephenie M Ortiz, Steven A Rubin, Steven Fong, MS, PhD, Steven J Libal, Steven M Weinman, Steven Oh, PhD, Steven P Donald, Suchan Kim, Susan A Zullo, PhD, Susan F Laska, MS, Susan M Halsted, Susan M Jackson, Susan P Bruederle, Susan Yu, Susanna E Ford, Susanne M Richardson, MS RAC, Swati Verma, Syeda N Mahazabin, Taichun Qin, PhD, Tamala P Bogan, Tamala P Magee, Tamara Brey, Tamara L Ely, Tamil Arasu, PhD, Tammy L Chavis, Tania E Vizcaino, Tania Y Hall, Tanya R Syffrard, Tara G Bizjak, Tara K Carmody, Tara R Gooen, Tej Poonai, Temar Q Williams, Teresita C Mercado, Thai D Truong, Theresa Kirkham (NMI), Thomas A Peter, Thomas E Friel, Thomas Finn, PhD, Thomas J Arista, Thomas J Cosgrove, Thomas J Mooney, Thomas R Withers, Thunder N Dunkijacobs, Thuy T Nguyen, LCDR, Tiffani D Wilson, Timothy T Kapsala, Tina S Roecklein, Todd M Stankewicz, Tonia F Bernard, Tonnie L Carter, Torrance J Slayton, Toyin B Oladimeji, Tracey Asinjen Wiersma, Travis R Hunt, Travis S Bradley, Travis V Hull, Tricia S Martinez, Troy C Quander, Truong Xuan Nguyen (Andy), Tyanna N Hadley, Uduak M Inokon, Unnee Ranjan, Valentino Fiorella, Valerie A Potopsingh, Valerie C Reed, Valerie Jgrecek Trinh, Valerie Reed, Vien Q Le, Vijaya L Simhadri, Vilmary Negron Rodriguez, Virgilio F Pacio, CSO, Virginia Carroll, PhD, Viviana Matta, Vivin George, Vlada Matusovsky, Walden H Lee, Wayne E Seifert, Wayne J Meyer, Wei Wang, PhD, Wendy G Tan, PhD, William D Bassett, Jr, William D Tingley, William J Leonard, William R Brubaker, William R Chang, Winston R Alejo, Xiao Wang, Xiaohan Cai, PhD, Xiaokuang Lai, PhD, Xikui Chen (nmi), PhD, Xiuju Lu, Yanming An, PhD, Yasamin Ameri, Yehualashet A Gessesse, Yi Wang, PhD, Yiping Jia, Yiwei Li, Yonggang Wang, PhD, Youmin Wang, Yumi J Hiramine, Yvesna C Blaise, Yvins Dezan, Yvonne C Mcknight, Zachary L Miller, Zakaria I Ganiyu, Zhong Li, PhD, Zuben E Sauna, PhD

Helen B Ricalde's Documents

Publish Date Document Type Title
June, 2023 FDA 483 CELGENE CORPORATION - Form 483, 2023-06-16
February, 2007 FDA 483 Dendreon Corporation - Form 483, 2007-02-16
July, 2016 FDA 483 Chartwell Pharmaceuticals Amityville, LLC. - Form 483, 2016-07-15
July, 2018 FDA 483 Hunter Holmes McGuire Veterans Affairs Medical Center Mammography - Form 483, 2018-07-19
December, 2004 FDA 483 JAK Diversified II, Inc. dba Multi-Pak Packaging - Form 483, 2004-12-30
July, 2011 EIR Abbott Laboratories - EIR, 2011-07-29
March, 2017 FDA 483 Fresenius Kabi USA, LLC - Form 483, 2017-03-30
February, 2016 FDA 483 Acorda Therapeutics, Inc. - Form 483, 2016-02-29
February, 2018 FDA 483 Chartwell Pharmaceuticals Carmel, LLC - Form 483, 2018-02-28
July, 2001 FDA 483 The P.F. Laboratories Inc. - Form 483, 2001-07-06
December, 2001 FDA 483 Imperial Drug And Spice Company - Form 483, 2001-12-05
July, 2012 FDA 483 Novartis Pharma AG - Form 483, 2012-07-26
July, 2001 EIR The P.F. Laboratories Inc. - EIR, 2001-07-06
October, 2014 FDA 483 American Regent, Inc. - Form 483, 2014-10-29
December, 2011 EIR Lonza Walkersville, Inc. - EIR, 2011-12-02
October, 2023 FDA 483 Alk-abello, Inc. - Form 483, 2023-10-17
August, 2004 FDA 483 Response Ortho-Clinical Diagnostics, Inc. - Form 483R, 2004-08-24
June, 2002 FDA 483 Response Sharp Corporation - Form 483R, 2002-06-25
January, 2011 FDA 483 Dendreon Corporation - Form 483, 2011-01-26
December, 2014 FDA 483 Taro Pharmaceuticals U.S.A., Inc. - Form 483, 2014-12-19
December, 2009 FDA 483 The American National Red Cross Diagnostic Manufacturing Division - Form 483, 2009-12-04
February, 2018 FDA 483 Response Chartwell Pharmaceuticals Carmel, LLC - Form 483R, 2018-03-20
July, 2001 FDA 483 Response The P.F. Laboratories Inc. - Form 483R, 2001-08-02
October, 2013 FDA 483 Millipore (U.K.) Ltd. - Form 483, 2013-10-04
December, 2004 FDA 483 Biomedical Tissue Services, Ltd - Form 483, 2004-12-02
June, 2010 FDA 483 Roche Diagnostics GmbH - Form 483, 2010-06-25
March, 2017 EIR Fresenius Kabi USA, LLC - EIR, 2017-03-30
June, 2004 FDA 483 Response Pliva, Inc. - Form 483R, 2004-06-16
September, 2003 FDA 483 Response Biomedical Tissue Services, Ltd - Form 483R, 2003-10-01
July, 2003 FDA 483 Unette Corporation - Form 483, 2003-07-18
June, 2002 FDA 483 Sharp Corporation - Form 483, 2002-06-14
February, 2004 FDA 483 Reed-Lane, Inc. - Form 483, 2004-02-04
February, 2004 EIR Reed-Lane, Inc. - EIR, 2004-02-04
October, 2002 FDA 483 Warner Chilcott US LLC - Form 483, 2002-10-18
December, 2008 FDA 483 Grifols Biologicals LLC - Form 483, 2008-12-12
July, 2009 FDA 483 Catalent Belgium SA - Form 483, 2009-07-20
January, 2005 FDA 483 Hoffmann La Roche Inc - Form 483, 2005-01-25
September, 2011 FDA 483 Rechon Life Science AB - Form 483, 2011-09-16
August, 2004 FDA 483 Ortho-Clinical Diagnostics, Inc. - Form 483, 2004-08-04
January, 2013 FDA 483 SANOFI WINTHROP INDUSTRIE - Form 483, 2013-01-23
April, 2012 FDA 483 Seqirus Pty Ltd - Form 483, 2012-04-24
June, 2011 EIR Baxter Pharmaceutical Solutions LLC - EIR, 2011-06-17
September, 2002 FDA 483 Bergen Comm Reg Blood Center - Form 483, 2002-09-20
September, 2003 EIR Ortho-Clinical Diagnostics, Inc. - EIR, 2003-09-25
February, 2007 EIR Dendreon Corporation - EIR, 2007-02-16
November, 2015 FDA 483 Chartwell Pharmaceuticals Carmel, LLC - Form 483, 2015-11-02
October, 2010 FDA 483 Wyeth Pharmaceutical Division of Wyeth Holdings LLC - Form 483, 2010-10-01
April, 2011 FDA 483 Merck Sharp & Dohme LLC - Form 483, 2011-04-27
July, 2012 FDA 483 GSK Vaccines GmbH - Form 483, 2012-07-17
February, 2004 FDA 483 Response Reed-Lane, Inc. - Form 483R, 2004-02-18
September, 2003 EIR Biomedical Tissue Services, Ltd - EIR, 2003-09-30
January, 2005 EIR Hoffmann La Roche Inc - EIR, 2005-01-25
November, 2016 EIR Chartwell Pharmaceuticals Congers, LLC. - EIR, 2016-11-01
August, 2014 FDA 483 OncoMed Pharmaceutical Services - Form 483, 2014-08-22
August, 2004 EIR Ortho-Clinical Diagnostics, Inc. - EIR, 2004-08-04
January, 2005 FDA 483 Response Hoffmann La Roche Inc - Form 483R, 2005-02-09
October, 2002 EIR Warner Chilcott US LLC - EIR, 2002-10-18
October, 2014 FDA 483 Spa Technologies International Inc - Form 483, 2014-10-03
July, 2016 FDA 483 Sanofi S.r.l. - Form 483, 2016-07-29
June, 2015 FDA 483 Rentschler Biopharma SE - Form 483, 2015-06-16
September, 2009 FDA 483 KP Pharmaceutical Technology, Inc. - Form 483, 2009-09-22
May, 2015 FDA 483 Cerovene, Inc. - Form 483, 2015-05-04
September, 2003 FDA 483 Biomedical Tissue Services, Ltd - Form 483, 2003-09-30
March, 2017 FDA 483 Strides Pharma, Inc - Form 483, 2017-03-16
June, 2004 FDA 483 Pliva, Inc. - Form 483, 2004-06-02
February, 2018 EIR Chartwell Pharmaceuticals Carmel, LLC - EIR, 2018-02-28
May, 2013 FDA 483 Lonza Biologics, Inc. - Form 483, 2013-05-02
October, 2012 EIR Fibrocell Technologies, Inc. - EIR, 2012-10-12
October, 2002 FDA 483 Response Warner Chilcott US LLC - Form 483R, 2002-11-15
December, 2011 FDA 483 Lonza Walkersville, Inc. - Form 483, 2011-12-02
November, 2015 EIR Chartwell Pharmaceuticals Carmel, LLC - EIR, 2015-11-02
November, 2016 FDA 483 Chartwell Pharmaceuticals Congers, LLC. - Form 483, 2016-11-01
April, 2016 FDA 483 Asept Pak Inc. - Form 483, 2016-04-21
May, 2016 FDA 483 Apotex Research Private Limited - Form 483, 2016-05-20
December, 2004 FDA 483 Hackensack University Medical Center - Form 483, 2004-12-15
December, 2016 FDA 483 Jd888 LLC - Form 483, 2016-12-21
June, 2002 EIR Sharp Corporation - EIR, 2002-06-14
January, 2002 EIR Abbott Laboratories - EIR, 2002-01-11
September, 2017 FDA 483 Eurofins PROXY Laboratories B.V. - Form 483, 2017-09-07
June, 2009 FDA 483 Bayer HealthCare LLC - Form 483, 2009-06-19
June, 2013 EIR Ajinomoto Althea, Inc. - EIR, 2013-06-11
June, 2004 EIR Pliva, Inc. - EIR, 2004-06-02
September, 2018 FDA 483 Ecometics, Inc. - Form 483, 2018-09-07
February, 2006 FDA 483 GlaxoSmithKline Consumer Healthcare, LP - Form 483, 2006-02-23
February, 2003 EIR Sharp Corporation - EIR, 2003-02-21
June, 2006 FDA 483 Unit Pack Co., Inc. - Form 483, 2006-06-06

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