Ralph M. Bernstein
FDA investigator
Appears on 10 documents from 2019 to 2025, most often at sites in India. Most often cites written procedures; deviations (21 CFR 211.100).
- 10
- Documents on file
- 6.7
- Observations per 483
- 2019
- First seen
- 2025
- Most recent
What they cite most
From 64 observations- 21 CFR 211.100Written procedures; deviations9
- 21 CFR 211.160General requirements9
- 21 CFR 211.113Control of microbiological contamination7
- 21 CFR 211.22Responsibilities of quality control unit6
- 21 CFR 211.68Automatic, mechanical, and electronic equipment5
- 21 CFR 211.67Equipment cleaning and maintenance4
Activity by year
2019: 2, 2022: 5, 2024: 2, 2025: 1
Where
India 3 · South Korea 2 · Switzerland 2 · Denmark 1 · Germany 1 · Japan 1
Often inspects with
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Inspection history
10 documents, newest first| Date | Firm | Location | Observations | Open |
|---|---|---|---|---|
| 2025-10-28 | 483 Lonza AGOct 28, 2025 · Visp, Switzerland | Visp, Switzerland | 4 | |
| 2024-03-25 | 483 Novo Nordisk A/SMar 25, 2024 · Kalundborg, Denmark | Kalundborg, Denmark | 8 | |
| 2024-02-27 | 483 CELLTRION IncFeb 27, 2024 · Incheon, South Korea | Incheon, South Korea | 10 | |
| 2022-08-26 | 483 Biocon Biologics LimitedAug 26, 2022 · Bengaluru, India | Bengaluru, India | 11 | |
| 2022-08-26 | 483 Biocon Biologics LimitedAug 26, 2022 · Bengaluru, India | Bengaluru, India | 7 | |
| 2022-08-13 | 483 Biocon Biologics LimitedAug 13, 2022 · Bengaluru, India | Bengaluru, India | 1 | |
| 2022-06-03 | 483 CELLTRION IncJun 3, 2022 · Incheon, South Korea | Incheon, South Korea | 7 |
About this profile
What does Ralph M. Bernstein inspect?
Ralph M. Bernstein appears on 10 documents on file covering 7 sites, most often in India.
What do they cite most often?
21 CFR 211.100 (written procedures; deviations), followed by 21 CFR 211.160 and 21 CFR 211.113.
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 Ralph M. Bernstein is dated Oct 28, 2025.