FDA Investigator Jay B Shah
Jay B Shah has inspections in 1 countries as of 21 Sep 2023. Jay B Shah has collaborated with a combinined 1018 experts on various inspections, contributing to compliance and improvement across diverse sectors.
Investigator Details
Number of Inspected Sites:
11
Last Inspection Date:
21 Sep 2023
Investigator Role:
FDA Investigator
Redica ID:
Country:
United States of America
Co-Investigator(s):
Addam S Reynolds,
Adetutu M Gidado,
Alberto A Viciedo,
Amy L Singer,
Amy M Cramer,
Annemarie Bodnar,
Atul J Agrawal,
Charlotte P Chang,
Christina K Theodorou,
Daniel J Grabicki,
David A Oluwo,
Devon Jenkins,
Douglas C Kovacs,
Edmund F Mrak, Jr,
Emest F Bizjak,
Emmanuel J Ramos,
Eric Rothschild,
Erin D Mccaffery,
Ernie F Bizkaj,
Frederick Razzaghi,
Helen Verdel,
James R Birkenstamm,
Jessica S Estriplet,
Jogy George,
Jonah S Ufferfilge,
Jose M Cayuela,
Jose O Hernandez,
Joy Rkozlowski Klena,
Juanita P Versace,
Justine Tomasso,
Karen E D'orazio,
Karishma G Gopaul,
Ko U Min,
Kristy A Zielny,
Lata C Mathew, PhD,
Loretta Nemchik,
Marcelo O Mangalindan, Jr,
Marea K Harmon,
Margaret M Sands,
Maria Estrella,
Michael Serrano,
Nicholas A Violand,
Niketa Patel,
Nikki S Ramirez,
Odera I Ekwunife,
Paul L Bellamy,
Pushpa S Jayasekara,
Regina T Brown,
Rose Ljean Mary,
Russell J Glapion,
Samir C Gala,
Stephenie M Ortiz,
Tamil Arasu, PhD,
Tara G Bizjak,
Unnee Ranjan,
Yong Wu, PhD,
Yoriann Mcabrera Bartolomei,
Yvins Dezan
Jay B Shah's Documents
Publish Date | Document Type | Title |
---|---|---|
September, 2021 | FDA 483 | International Trading Pharm Lab Inc - Form 483, 2021-09-16 |
October, 2022 | FDA 483 | Cyalume Specialty Products - Form 483, 2022-10-03 |
June, 2021 | FDA 483 | Tris Pharma Inc - Form 483, 2021-06-08 |
June, 2022 | FDA 483 | Hikma Injectables USA Inc. - Form 483, 2022-06-08 |
July, 2022 | FDA 483 | Innovation Labs, Inc. - Form 483, 2022-07-05 |
May, 2022 | FDA 483 | MD Pharmaceutical Supply, LLC - Form 483, 2022-05-09 |
December, 2021 | FDA 483 | Aurolife Pharma LLC - Form 483, 2021-12-07 |
February, 2022 | FDA 483 | SHUZY ROCK INC - Form 483, 2022-02-14 |
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