Rachael O. Oyewole
FDA investigator
Appears on 10 documents from 2020 to 2023, most often at sites in Pennsylvania. Most often cites production record review (21 CFR 211.192).
- 10
- Documents on file
- 5.5
- Observations per 483
- 2020
- First seen
- 2023
- Most recent
What they cite most
From 55 observations- 21 CFR 211.192Production record review7
- 21 CFR 211.22Responsibilities of quality control unit7
- 21 CFR 211.67Equipment cleaning and maintenance6
- 21 CFR 211.25(a)Personnel qualifications5
- 21 CFR 211.100Written procedures; deviations4
- 21 CFR 211.160General requirements3
Activity by year
2020: 2, 2021: 2, 2022: 3, 2023: 3
Where
Pennsylvania 4 · India 2 · New Jersey 2 · Maryland 1 · New York 1
Often inspects with
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Inspection history
10 documents, newest first| Date | Firm | Location | Observations | Open |
|---|---|---|---|---|
| 2023-04-28 | 483 K PATEL PHYTO EXTRACTIONS PRIVATE LIMITEDApr 28, 2023 · Valsad, India | Valsad, India | 1 | |
| 2023-04-21 | 483 MSN Pharmachem Private LimitedApr 21, 2023 · Patancheru (Mandal), India | Patancheru (Mandal), India | 1 | |
| 2023-02-15 | 483 Veranova, L.P.Feb 15, 2023 · West Deptford, New Jersey | West Deptford, New Jersey | 2 | |
| 2022-11-14 | 483 Pharmaceutics International, Inc.Nov 14, 2022 · Cockeysville, Maryland | Cockeysville, Maryland | 10 | |
| 2022-07-27 | 483 Renu Laboratories, LLCJul 27, 2022 · Warminster, Pennsylvania | Warminster, Pennsylvania | 7 | |
| 2022-05-16 | 483 Premier Brands of America IncMay 16, 2022 · Orangeburg, New York | Orangeburg, New York | 6 | |
| 2021-08-31 | 483 Teligent, Inc.Aug 31, 2021 · Buena, New Jersey | Buena, New Jersey | 15 |
About this profile
What does Rachael O. Oyewole inspect?
Rachael O. Oyewole appears on 10 documents on file covering 10 sites, most often in Pennsylvania.
What do they cite most often?
21 CFR 211.192 (production record review), followed by 21 CFR 211.22 and 21 CFR 211.67.
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 Rachael O. Oyewole is dated Apr 28, 2023.