Amylin Pharmaceuticals Inc.
Form 483 issued January 21, 2025 · West Chester, Ohio
- Inspection
- Dec 16, 2024 – Jan 21, 2025
- Investigators
- Karen A. Briggs· Rafeeq Habeeb
- Observations
- 6
- Pages
- 7
- FEI number
- 3006316363
In short: On January 21, 2025, FDA issued a Form 483 with 6 observations to Amylin Pharmaceuticals Inc. in West Chester, Ohio (FEI 3006316363) after an inspection that ran Dec 16, 2024 – Jan 21, 2025. The investigators were Karen A. Briggs and Rafeeq Habeeb. Most observations concern production and laboratory controls; the most-cited regulation is 21 CFR 211.194 (laboratory records).
At a glance
Production and laboratory controls account for 4 of 6 observations.
What FDA observed
Preview: the opening words of each observation- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not…
- 02
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 03
Each lot of a drug product container and closure that is liable to microbiological contamination that…
- 04
Laboratory records are deficient in that they do not include the initials and signature of the…
This inspection in context
Karen A. Briggs
19 documents · 2021–2026
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Virginia.
The firmAmylin Pharmaceuticals Inc. history
All 4 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.113(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Amylin Pharmaceuticals Inc.?
FDA listed 6 observations on this Form 483, mostly about production, laboratory controls and quality system. The most-cited regulation is 21 CFR 211.194 (laboratory records). The opening words of each observation are shown on this page.
Who inspected Amylin Pharmaceuticals Inc.?
Karen A. Briggs and Rafeeq Habeeb are named on this Form 483, for the inspection of Dec 16, 2024 – Jan 21, 2025. Each investigator has a profile showing what they cite most.
When was Amylin Pharmaceuticals Inc. inspected by FDA?
The inspection ran Dec 16, 2024 – Jan 21, 2025, and the Form 483 is dated January 21, 2025.
How do I get the full Form 483 for Amylin Pharmaceuticals Inc.?
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