Esther C. Broner
FDA investigator
Appears on 4 documents from 2022 to 2024, mostly at sites in Indiana. Most often cites control of microbiological contamination (21 CFR 211.113).
- 4
- Documents on file
- 4.0
- Observations per 483
- 2022
- First seen
- 2024
- Most recent
What they cite most
From 14 observations- 21 CFR 211.113Control of microbiological contamination6
- 21 CFR 211.100Written procedures; deviations2
- 21 CFR 211.192Production record review2
- 21 CFR 211.22Responsibilities of quality control unit2
- 21 CFR 211.67Equipment cleaning and maintenance2
- 21 CFR 211.68Automatic, mechanical, and electronic equipment2
Activity by year
2022: 1, 2023: 2, 2024: 1
Where
Indiana 2 · California 1 · Israel 1
Often inspects with
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Inspection history
4 documents, newest first| Date | Firm | Location | Observations | Open |
|---|---|---|---|---|
| 2024-02-06 | 483 Amgen, IncFeb 6, 2024 · Thousand Oaks, California | Thousand Oaks, California | 5 | |
| 2023-08-12 | 483 Catalent Indiana, LLCAug 12, 2023 · Bloomington, Indiana | Bloomington, Indiana | 3 | |
| 2023-05-12 | 483 Catalent Indiana, LLCMay 12, 2023 · Bloomington, Indiana | Bloomington, Indiana | 3 | |
| 2022-11-15 | 483 MediWound LtdNov 15, 2022 · Yavne, Israel | Yavne, Israel | 5 |
About this profile
What does Esther C. Broner inspect?
Esther C. Broner appears on 4 documents on file covering 4 sites, mostly in Indiana.
What do they cite most often?
21 CFR 211.113 (control of microbiological contamination), followed by 21 CFR 211.100 and 21 CFR 211.192.
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 Esther C. Broner is dated Feb 6, 2024.