Amylin Pharmaceuticals Inc.
FDA inspection history in West Chester, Ohio, 2009 to 2025
- 4
- Form 483s
Every document, by year
- Form 483
2009: one Form 483; 2019: one Form 483; 2022: one Form 483; 2025: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2009One Form 483, at West Chester, Ohio.
- 2009The longest 483 on file: 10 observations over 7 pages at West Chester, Ohio.
- 2019One Form 483, at West Chester, Ohio.
- 2022One Form 483, at West Chester, Ohio.
- 2025One Form 483, at West Chester, Ohio.
Cited most
Across all Amylin Pharmaceuticals observations on file
- 21 CFR 211.192Production record review5
- 21 CFR 211.100Written procedures; deviations3
- 21 CFR 211.194Laboratory records3
- 21 CFR 211.25Personnel qualifications3
- 21 CFR 211.113Control of microbiological contamination2
The complete Amylin Pharmaceuticals file.
All 4 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
West Chester, Ohio
Four Form 483s · 2009 to 2025 · 24 observations
Latest: Form 483, Jan 21, 2025 →
Documents
4 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2025-01-21 | 483 Form 483 | West Chester, Ohio | 6 | $99 |
| 2022-05-25 | 483 Form 483 | West Chester, Ohio | 5 | $99 |
| 2019-08-09 | 483 Form 483 | West Chester, Ohio | 3 | $99 |
| 2009-12-23 | 483 Form 483 | West Chester, Ohio | 10 | $99 |
Investigators on these documents
Anna M. Brannen (1)Elizabeth L. Loreaux (1)Karen A. Briggs (1)Nicholas L. Paulin (1)Rafeeq Habeeb (1)Richard T. Riggie (1)
FEI number 3006316363 · most recent document Jan 21, 2025
About Amylin Pharmaceuticals Inc.
How many FDA Form 483s has Amylin Pharmaceuticals Inc. received?
FDA Intel has 4 Form 483s on file for Amylin Pharmaceuticals Inc.; the most recent is dated Jan 21, 2025.
When was Amylin Pharmaceuticals Inc. last inspected by FDA?
The most recent FDA inspection document on file for Amylin Pharmaceuticals Inc. is a Form 483 dated Jan 21, 2025, for the site in West Chester, Ohio.
What did FDA cite at Amylin Pharmaceuticals Inc.?
The regulations cited most in the observations on file for Amylin Pharmaceuticals Inc. are 21 CFR 211.192 (Production record review), 5 times; 21 CFR 211.100 (Written procedures; deviations), 3 times; 21 CFR 211.194 (Laboratory records), 3 times.