Jay B. Shah
FDA investigator
Appears on 5 documents from 2021 to 2026, mostly at sites in New Jersey. Most often cites responsibilities of quality control unit (21 CFR 211.22).
- 5
- Documents on file
- 4.6
- Observations per 483
- 2021
- First seen
- 2026
- Most recent
What they cite most
From 23 observations- 21 CFR 211.22Responsibilities of quality control unit3
- 21 CFR 211.67(a)Equipment cleaning and maintenance3
- 21 CFR 211.160General requirements2
- 21 CFR 211.192Production record review2
- 21 CFR 211.42(c)(10)(iii)Design and construction features2
- 21 CFR 211.58Maintenance2
Activity by year
2021: 2, 2022: 2, 2026: 1
Where
New Jersey 5
Often inspects with
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Inspection history
5 documents, newest first| Date | Firm | Location | Observations | Open |
|---|---|---|---|---|
| 2026-02-17 | 483 BeOne Medicines USA, Inc.Feb 17, 2026 · Pennington, New Jersey | Pennington, New Jersey | 1 | |
| 2022-10-03 | 483 Cyalume Specialty Products IncOct 3, 2022 · Bound Brook, New Jersey | Bound Brook, New Jersey | 3 | |
| 2022-06-08 | 483 Hikma Injectables USA Inc.Jun 8, 2022 · Dayton, New Jersey | Dayton, New Jersey | 3 | |
| 2021-12-07 | 483 Aurolife Pharma LLCDec 7, 2021 · Dayton, New Jersey | Dayton, New Jersey | 9 | |
| 2021-06-08 | 483 Tris Pharma IncJun 8, 2021 · Monmouth Junction, New Jersey | Monmouth Junction, New Jersey | 7 |
About this profile
What does Jay B. Shah inspect?
Jay B. Shah appears on 5 documents on file covering 5 sites, mostly in New Jersey.
What do they cite most often?
21 CFR 211.22 (responsibilities of quality control unit), followed by 21 CFR 211.67(a) and 21 CFR 211.160.
Can I read the observations?
Each document page previews the opening words of every observation. The full documents are available to buy, one at a time or together.
How current is this profile?
The most recent document on file for Jay B. Shah is dated Feb 17, 2026.