Samir C. Gala
FDA investigator
Appears on 10 documents from 2020 to 2024, mostly at sites in Connecticut. Most often cites equipment cleaning and maintenance (21 CFR 211.67).
- 10
- Documents on file
- 5.4
- Observations per 483
- 2020
- First seen
- 2024
- Most recent
What they cite most
From 54 observations- 21 CFR 211.67Equipment cleaning and maintenance8
- 21 CFR 211.42Design and construction features7
- 21 CFR 211.100Written procedures; deviations4
- 21 CFR 211.166Stability testing4
- 21 CFR 211.192Production record review4
- 21 CFR 211.68Automatic, mechanical, and electronic equipment4
Activity by year
2020: 1, 2021: 1, 2022: 4, 2023: 1, 2024: 3
Where
Connecticut 5 · New Jersey 2 · New York 1 · Spain 1 · Vermont 1
Often inspects with
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Inspection history
10 documents, newest first| Date | Firm | Location | Observations | Open |
|---|---|---|---|---|
| 2024-12-20 | 483 SCA Pharmaceuticals, LLCDec 20, 2024 · Windsor, Connecticut | Windsor, Connecticut | 7 | |
| 2024-05-15 | 483 Aurobindo Pharma USA Inc.May 15, 2024 · East Windsor, New Jersey | East Windsor, New Jersey | 2 | |
| 2024-02-20 | 483 SCA Pharmaceuticals, LLCFeb 20, 2024 · Windsor, Connecticut | Windsor, Connecticut | 7 | |
| 2023-09-15 | 483 Italfarmaco S.A.Sep 15, 2023 · Alcobendas, Spain | Alcobendas, Spain | 1 | |
| 2022-08-12 | 483 RK PHARMA INC.Aug 12, 2022 · Pearl River, New York | Pearl River, New York | 4 | |
| 2022-06-08 | 483 Hikma Injectables USA Inc.Jun 8, 2022 · Dayton, New Jersey | Dayton, New Jersey | 3 | |
| 2022-04-26 | 483 American Distilling Inc.Apr 26, 2022 · East Hampton, Connecticut | East Hampton, Connecticut | 4 |
About this profile
What does Samir C. Gala inspect?
Samir C. Gala appears on 10 documents on file covering 9 sites, mostly in Connecticut.
What do they cite most often?
21 CFR 211.67 (equipment cleaning and maintenance), followed by 21 CFR 211.42 and 21 CFR 211.100.
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 Samir C. Gala is dated Dec 20, 2024.