Lewis K. Antwi
FDA investigator
Appears on 11 documents from 2019 to 2025, most often at sites in Pennsylvania. Most often cites production record review (21 CFR 211.192).
- 11
- Documents on file
- 2.6
- Observations per 483
- 2019
- First seen
- 2025
- Most recent
What they cite most
From 26 observations- 21 CFR 211.192Production record review6
- 21 CFR 211.160General requirements4
- 21 CFR 211.84Testing and approval or rejection of components, drug product containers, and closures4
- 21 CFR 211.113Control of microbiological contamination3
- 21 CFR 211.67Equipment cleaning and maintenance3
- 21 CFR 211.100Written procedures; deviations2
Activity by year
2019: 1, 2022: 4, 2023: 1, 2024: 3, 2025: 2
Where
Pennsylvania 2 · California 1 · Indiana 1 · Italy 1 · Massachusetts 1 · New Hampshire 1
Often inspects with
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Inspection history
11 documents, newest first| Date | Firm | Location | Observations | Open |
|---|---|---|---|---|
| 2025-01-30 | 483 FDA Form 483 Krystal Biotech Inc., Pittsburgh, PA Jan 2025Jan 30, 2025 · Pittsburgh, Pennsylvania | Pittsburgh, Pennsylvania | — | |
| 2025-01-30 | 483 Krystal Biotech, Inc.Jan 30, 2025 · Pittsburgh, Pennsylvania | Pittsburgh, Pennsylvania | — | |
| 2024-11-22 | 483 Wyeth Farma SANov 22, 2024 · San Sebastian de los Reyes, Spain | San Sebastian de los Reyes, Spain | 2 | |
| 2024-05-28 | 483 FinVector OyMay 28, 2024 | — | 5 | |
| 2024-03-07 | 483 Lonza Houston Inc.Mar 7, 2024 · Portsmouth, New Hampshire | Portsmouth, New Hampshire | — | |
| 2023-08-30 | 483 Brammer Bio MA, LLCAug 30, 2023 · Cambridge, Massachusetts | Cambridge, Massachusetts | — | |
| 2022-11-18 | 483 Wyeth Pharmaceutical Division of Wyeth Holdings LLCNov 18, 2022 · Sanford, North Carolina | Sanford, North Carolina | 2 |
About this profile
What does Lewis K. Antwi inspect?
Lewis K. Antwi appears on 11 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 211.160 and 21 CFR 211.84.
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 Lewis K. Antwi is dated Jan 30, 2025.