Niketa Patel
FDA investigator
Appears on 15 documents from 2016 to 2023, most often at sites in New Jersey. Most often cites production record review (21 CFR 211.192).
- 15
- Documents on file
- 4.0
- Observations per 483
- 2016
- First seen
- 2023
- Most recent
What they cite most
From 60 observations- 21 CFR 211.192Production record review7
- 21 CFR 211.22Responsibilities of quality control unit7
- 21 CFR 211.194(a)Laboratory records5
- 21 CFR 211.25Personnel qualifications5
- 21 CFR 211.67Equipment cleaning and maintenance5
- 21 CFR 211.113Control of microbiological contamination4
Activity by year
2016: 2, 2017: 1, 2018: 6, 2019: 4, 2020: 1, 2023: 1
Where
New Jersey 6 · China 2 · India 2 · Japan 2 · Germany 1 · New York 1
Often inspects with
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Inspection history
15 documents, newest first| Date | Firm | Location | Observations | Open |
|---|---|---|---|---|
| 2023-09-13 | 483 Wuxi Fortune Pharmaceutical Co., Ltd.Sep 13, 2023 · Wuxi, China | Wuxi, China | 3 | |
| 2020-02-07 | 483 Pfizer Manufacturing Deutschland GmbHFeb 7, 2020 · Freiburg im Breisgau, Germany | Freiburg im Breisgau, Germany | 3 | |
| 2019-11-08 | 483 QUAGEN PHARMACEUTICALS LLCNov 8, 2019 · West Caldwell, New Jersey | West Caldwell, New Jersey | 3 | |
| 2019-10-29 | 483 International Trading Pharm Lab IncOct 29, 2019 · Paterson, New Jersey | Paterson, New Jersey | 6 | |
| 2019-07-25 | 483 Mandell's Clinical PharmacyJul 25, 2019 · Somerset, New Jersey | Somerset, New Jersey | 5 | |
| 2019-05-22 | 483 Unither Manufacturing LLCMay 22, 2019 · Rochester, New York | Rochester, New York | 3 | |
| 2018-10-24 | 483 JO Cosmetics Co., Ltd.Oct 24, 2018 · Hanyu, Japan | Hanyu, Japan | 4 |
About this profile
What does Niketa Patel inspect?
Niketa Patel appears on 15 documents on file covering 14 sites, most often in New Jersey.
What do they cite most often?
21 CFR 211.192 (production record review), followed by 21 CFR 211.22 and 21 CFR 211.194(a).
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 Niketa Patel is dated Sep 13, 2023.