Nesher Pharmaceuticals (USA) LLC
FDA inspection history in Bridgeton, Missouri, 2019 to 2021
- 3
- Form 483s
Every document, by year
- Form 483
2019: two Form 483s; 2021: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2019–21Three Form 483s, at Bridgeton, Missouri.
- 2019The longest 483 on file: 8 observations over 10 pages at Bridgeton, Missouri.
Cited most
Across all Nesher Pharmaceuticals (USA) observations on file
- 21 CFR 211.192Production record review4
- 21 CFR 211.100Written procedures; deviations1
- 21 CFR 211.113Control of microbiological contamination1
- 21 CFR 211.160General requirements1
- 21 CFR 211.165Testing and release for distribution1
The complete Nesher Pharmaceuticals (USA) file.
All 3 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Bridgeton, Missouri
Three Form 483s · 2019 to 2021 · 13 observations
Latest: Form 483, Aug 12, 2021 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2021-08-12 | 483 Form 483 | Bridgeton, Missouri | 2 | $99 |
| 2019-07-31 | 483 Form 483 | Bridgeton, Missouri | 3 | $99 |
| 2019-05-31 | 483 Form 483 | Bridgeton, Missouri | 8 | $99 |
Investigators on these documents
Alan M. Barker (1)Ana P. Sandee (1)Bei Y. He (1)Robert J. Ham (1)Wayne D. McGrath (1)William Fred Lagud Jr (1)
FEI number 1922352 · most recent document Aug 12, 2021
About Nesher Pharmaceuticals (USA) LLC
How many FDA Form 483s has Nesher Pharmaceuticals (USA) LLC received?
FDA Intel has 3 Form 483s on file for Nesher Pharmaceuticals (USA) LLC; the most recent is dated Aug 12, 2021.
When was Nesher Pharmaceuticals (USA) LLC last inspected by FDA?
The most recent FDA inspection document on file for Nesher Pharmaceuticals (USA) LLC is a Form 483 dated Aug 12, 2021, for the site in Bridgeton, Missouri.
What did FDA cite at Nesher Pharmaceuticals (USA) LLC?
The regulations cited most in the observations on file for Nesher Pharmaceuticals (USA) LLC are 21 CFR 211.192 (Production record review), 4 times; 21 CFR 211.100 (Written procedures; deviations), 1 time; 21 CFR 211.113 (Control of microbiological contamination), 1 time.