FDA Investigator Niketa Patel

Niketa Patel has inspections in 13 countries as of 07 Dec 2023. Niketa Patel has collaborated with a combinined 5361 experts on various inspections, contributing to compliance and improvement across diverse sectors.

Investigator Details

Number of Inspected Sites:
133
Last Inspection Date:
07 Dec 2023
Investigator Role:
FDA Investigator
Redica ID:
Country:
United States of America, China, Germany, India, Mexico, Japan, Hong Kong, Italy, Jordan, Czechia, United Kingdom of Great Britain and Northern Ireland, Switzerland
Co-Investigator(s):
Addam S Reynolds, Adetutu M Gidado, Alberto A Viciedo, Alice S Tsao, Alicia M Mozzachio, Amatul H Marium, Amit Kokate, Amy L Singer, Amy M Cramer, Ana P Pineda Zavaleta, Anita Narula, PhD, Anita R Michael, Ankur C Patel, Ann Marie Montemurro, Annemarie Bodnar, Anthony A Charity, Anthony J Donato, Arsen Karapetyan, Arthur G Hurst, Ashar P Parikh, Atul J Agrawal, Azza Talaat, Barbara J Maulfair, Barbara J Wilimczyk, Barbara Jwilimczyk Macri, Barbara M Frazier, Bijoy Panicker, Bonita S Chester, Brandy N Lepage, Bruce G Cooper, Carmen Y Fisher, Carol L Rehkopf, Cary Greene, Chaoying C Ma, Charles J Chacko, Chikako Torigoe, PhD, Christian D Lynch (CDL), Christie A Soto, Christine M Cerenzio, Chunsheng Cai, PhD, Constance Y Fears, Constantin Y Philopoulos, Craig W Swanson, Cynthia Jim, CSO, Daniel J Grabicki, Daniel J Min, Daniel J Roberts, Daniel L Aisen, Danielle Lyke, David A Oluwo, David Faranda, David M Mcnew, David Perkins, Dawn E Barkans, Dawn L Wydner, Deborah B Nixon, Deborah J Parris, Demitria J Xiradakis, Devaughn Edwards, Devon Jenkins, Dinesh Kumar, Dorothy J Denes, Douglas C Kovacs, Dr. Jason R Caballero, Edmund F Mrak, Jr, Emest F Bizjak, Emil P Wang, JD, Emmanuel J Ramos, Eric Rothschild, Erik W Koester, Erika V Butler, Erin D Mccaffery, Farhana Khan, Frank J Marciniak, Frank Wackes, Frederick Razzaghi, Gabriel E Muniz, Gajendiran Mahadevan, PhD, Gale E Ryan, George Pyramides, Gianine E Delade, Gianine E Tompkins, Gloria E Parra, Guerlain Ulysse, Haitao Li, Harry J Brewer, Helen B Ricalde, Helen Verdel, Heriberto Negron Rivera, Himanshu Gupta, PhD, Ivis Lnegron Torres, Jacqueline Mdiaz Albertini, James A Lentz, James L Dunnie, Jr, James M Mason, James R Birkenstamm, Janet A Rajan, Jason D Tenney, Javier E Santos, Jawaid Hamid, Jay B Shah, Jean Blackston Hill, Jean Blackstone Hill, Jeffery B Medwid, PhD, Jennifer D Hollstrom, Jessica M Monteiro, Jessica S Estriplet, Joan A Loreng, Joanne Heim, Jocelyn E Massey, Jogy George, John A Podsadowski, John P Mistler, Johnna L Bleem, Jonah S Ufferfilge, Jonee J Mearns, Jose Acruz Gonzalez, Jose E Melendez, DDC, Jose M Cayuela, Jose R Hernandez, Joseph F Mcginnis, RPh, Joseph J Vannelli, Josh Renzon Ramilo, Joy R Kozlowski, Joy Rkozlowski Klena, Juanita P Versace, Justin A Hefferman, Justine Tomasso, Karen E D'orazio, Karen L Kosar, Katie L Penno, Keith M Reilly, Kelli F Dobilas, Kelli F Regenye, Kelli F Regenyl, Kelli Regente, Kellia N Hicks, Kelvin Cheung, Kham Phommachanh, Kimberley A Hoefen, King, Kristina L Conroy, Kristy A Zielny, Kyle D Covill, Laishan L Lam, Lance M De Souza, MBA, Larry K Austin, Lata C Mathew, PhD, Laura D Cain, Lawrence R Johnson, LCDR Audra J Lenhart, LCDR Chad N Thompson, Li Li, Liatte Kreuger, PharmD, Linda F Murphy, Lloyd D Payne, Luis A Dasta, Maotang Xhou, Maotang Zhou, PhD, Marcellinus D Dordunoo, Margaret E Sarles, Maria Estrella, Marianela Aponte Cruz, Marie Bbuen Bigornia, Marvin D Jones, Masfin Abdi, Matthew A Spataro, Matthew B Casale, Matthew R Mcnew, Meisha R Sampson, Meisha Waters, Melanie M Walker, Melba Trivera Clavell, Melissa B Libby, Melissa D Ray, Melissa T Roy, Merril E Racke, Meyer J Slobotsky, Michael A Charles, Michael E Maselli, Michael Gurbarg, Michael J Nerz, Michael L Casner, Michael P Sheehan, Michael R Klapal, Michael Serrano, Michele Gottshall, Michele Perry Williams, Michelle Y Clark Stuart, Monika Borkowska, Mra Davism, Mra M Barbosar, Mra Mcculloughj, Muralidhara B Gavini, PhD, Myckie M Jacobsen, Nadeem I Chaudhry, Nancy F Scheraga, Nancy L Rolli, Nancy M Espinal, Nerizza B Guerin, Nicholas A Violand, Nicholas E Squillante, Nicholas L Paulin, Nikki S Ramirez, Noreen Muniz, Odera I Ekwunife, Parul M Patel, Patricia Fhughes Troost, Patricia H Dlugosz, Patrick L Wisor, Paul L Bellamy, Paul M Kawamoto, Paul Mouris, Peter R Lenahan, Prabhu P Raju, Pushpa S Jayasekara, Rachael A Moliver, Rafael Nevarez Nieves, Rakhi B Shah, Raymond T Oji, Rebecca E Dombrowski, Regina T Brown, Remache, Reyes Candau Chacon, PhD, Richard H Penta, Richard J Muzeni, Richard W Thornton, Richard W Thorntton, Robert C Steyert, Robert D Tollefsen, Robert Sharpnack, Robin P Mathew, Rochelle L Campbell, Rochelle L Cross, Rodrigo Vilchez, Rose Ljean Mary, Russ E Davis, Russell J Glapion, Sachinkumar V Patel, Samantha J Bradley, Samanthan J Bradley, Samina S Khan, Samir C Gala, Samuel A Hamblin, Sandra A Hughes, Sarah Adella Fave, Sayyem H Akbar, Sean R Marcsisin, Sherri J Liu, Sidney B Priesmeyer, Simone E Pitts, Sinai Davis, Stacie A Woods, State Agency, Stephanie T Durso, Stephen D Brown, Stephen J Mottola, Stephenie M Ortiz, Steve Y Rhieu, PhD, Steven B Hertz, Steven D Kehoe, Steven P Donald, Sunita Iyer, Susan F Laska, MS, Susan M Halsted, Susan W Ting, Syeda N Mahazabin, Tamil Arasu, PhD, Tanya R Syffrard, Tara G Bizjak, Tara R Gooen, Temar Q Williams, Theresa Kirkham (NMI), Thomas J Arista, Thuy T Nguyen, LCDR, Timothy M Albright, Tina M Pawlowski, Tonia F Bernard, Torrance J Slayton, Tressa T Lewis, Truong Xuan Nguyen (Andy), Unnee Ranjan, Valerie C Reed, Valerie Reed, Victoria Spivak, Walden H Lee, Wayne E Seifert, Wayne S Fortenberry, Wei Huaemily Wu, William J Leonard, William R Chang, Willy A Orantes, Xianghong Jing (Emily), PhD, Xiaohan Cai, PhD, Xiomara Copeland, Yoriann Mcabrera Bartolomei, Young Kim, Yvesna C Blaise, Yvins Dezan, Zakaria I Ganiyu, Zhe J Tang, Zhijin Chen

Niketa Patel's Documents

Publish Date Document Type Title
February, 2017 EIR Teva Pharmaceuticals USA, Inc. - EIR, 2017-02-01
January, 2015 EIR RICONPHARMA LLC - EIR, 2015-01-21
October, 2018 FDA 483 Tokyo Chemical Industry Co., Ltd. - Form 483, 2018-10-19
January, 2018 FDA 483 Scientech Laboratories, Inc. - Form 483, 2018-01-19
October, 2019 FDA 483 International Trading Pharm Lab Inc - Form 483, 2019-10-29
May, 2019 FDA 483 Unither Manufacturing LLC - Form 483, 2019-05-22
December, 2019 FDA 483 Response Halo Pharmaceutical Inc - Form 483R, 2020-01-13
March, 2016 FDA 483 Leading Pharma, LLC - Form 483, 2016-03-11
October, 2018 FDA 483 JO Cosmetics Co., Ltd. - Form 483, 2018-10-24
December, 2019 FDA 483 Halo Pharmaceutical Inc - Form 483, 2019-12-20
October, 2017 FDA 483 DERMARITE INDUSTRIES, LLC - Form 483, 2017-10-30
May, 2015 FDA 483 Myra's Bakery, Inc. - Form 483, 2015-05-15
May, 2018 FDA 483 Eugia SEZ Private Limited - Form 483, 2018-05-04
July, 2019 FDA 483 Mandell's Clinical Pharmacy - Form 483, 2019-07-25
May, 2019 FDA 483 Response Unither Manufacturing LLC - Form 483R, 2019-05-22
October, 2018 FDA 483 JO COSMETICS CO., LTD. - Form 483, 2018-10-26
September, 2015 FDA 483 Integrated Analytical Laboratories, LLC. - Form 483, 2015-09-08
April, 2016 FDA 483 International Trading Pharm Lab Inc - Form 483, 2016-04-29
December, 2018 EIR Laboratory Service Inc. - EIR, 2018-12-18
November, 2015 EIR Welch, Holme & Clark Co.,Inc. - EIR, 2015-11-19
June, 2018 FDA 483 Procter & Gamble Manufacturing México, S. de R.L. de C.V. - Form 483, 2018-06-15
December, 2015 FDA 483 Pierre Fabre Dermo Cosmetique - Form 483, 2015-12-30
August, 2018 EIR Changzhou Maokang Medical Products Co., Ltd - EIR, 2018-10-03
February, 2017 EIR Amneal Pharmaceuticals, LLC - EIR, 2017-02-21
August, 2015 FDA 483 Actavis Elizabeth LLC - Form 483, 2015-08-27
December, 2018 FDA 483 Laboratory Service Inc. - Form 483, 2018-12-18
April, 2017 EIR Elite Laboratories, Inc. - EIR, 2017-04-24
April, 2018 FDA 483 Amneal Pharmaceuticals Private Limited - Form 483, 2018-04-24
April, 2015 FDA 483 Dermaceutical Laboratories Limited Liability Company - Form 483, 2015-04-06
October, 2017 EIR DERMARITE INDUSTRIES, LLC - EIR, 2017-10-30
May, 2019 EIR Unither Manufacturing LLC - EIR, 2019-05-22
February, 2017 FDA 483 Teva Pharmaceuticals USA, Inc. - Form 483, 2017-02-01
December, 2019 EIR Halo Pharmaceutical Inc - EIR, 2019-12-20
January, 2015 FDA 483 RICONPHARMA LLC - Form 483, 2015-01-21
February, 2017 FDA 483 Response Teva Pharmaceuticals USA, Inc. - Form 483R, 2017-02-23
November, 2019 FDA 483 QUAGEN PHARMACEUTICALS LLC - Form 483, 2019-11-08
August, 2018 FDA 483 Changzhou Maokang Medical Products Co., Ltd - Form 483, 2018-08-24
August, 2018 FDA 483 Lights Medical Manufacture Co., Ltd. - Form 483, 2018-08-17
April, 2019 FDA 483 Colonia Care Pharmacy - Form 483, 2019-04-22
August, 2017 EIR Curia New Jersey, LLC - EIR, 2017-08-28
April, 2017 FDA 483 Elite Laboratories, Inc. - Form 483, 2017-04-24
August, 2017 EIR BioSpectra Inc. - EIR, 2017-08-01
February, 2020 FDA 483 Pfizer Manufacturing Deutschland GmbH - Form 483, 2020-02-07
March, 2018 FDA 483 Edge Pharma, LLC - Form 483, 2018-03-08
August, 2018 FDA 483 North China Pharmaceutical Huasheng Co., Ltd. - Form 483, 2018-08-10
August, 2023 FDA 483 BrightGene Bio-Medical Technology Co., Ltd. - Form 483, 2023-08-10

Experience Redica System's NEW investigator profiles and dashboards

Redica Systems customers get access to over 1,400 FDA Investigator profiles, containing powerful analysis like:

  • Total inspections conducted
  • 483 rate
  • OAI rate
  • Warning Letter rate
  • Inspections by Industry, Scope, and Inspection Reason
  • And much more

Investigator Profiles are not sold as on-demand documents. If you’d like to see one, fill out the form below to connect with our Sales Team and get it in your inbox as little as 24 hours.


Talk to sales to access our investigator profiles

Loading...

Investigator Profiles Are Just the Tip of the Iceberg

Becoming a Redica Systems customer not only provides you with unlimited access to profiles similar to the one above for every current and former FDA Investigator, but also grants you access to:

Inspection Intelligence

  • Pre-Approval Inspection (PAI) trends
  • The ability to filter nearly any FDA enforcement action by GxP labels like GMP, GCP, etc.
  • Latest 483s: see what the trends are across all FDA Investigators
  • CFR Heatmap: Citations aggregated by Subpart by Year

Vendor Intelligence

  • Full inspection histories for your vendors down to the specific site level
  • All of the functionality mentioned above but isolated to just your vendors

Regulatory Intelligence

  • Zero in on the trends for a specific agency/regulator (ex. FDA, MHRA, EMA, Health Canada)
  • All the latest "Signals" from agencies around the world, segmented by Country, Type (ex. Guidance, Decree...), Category (ex. Rules/Regulations/Guidance, News, Reports...), Theme (ex. Cell and Gene Therapy, AI...), and more