Amylin Pharmaceuticals Inc.
Form 483 issued December 23, 2009 · West Chester, Ohio
- Inspection
- Feb 7 – Dec 23, 2009
- Investigators
- Anna M. Brannen· Elizabeth L. Loreaux· Nicholas L. Paulin
- Observations
- 10
- Pages
- 7
- FEI number
- 3006316363
In short: On December 23, 2009, FDA issued a Form 483 with 10 observations to Amylin Pharmaceuticals Inc. in West Chester, Ohio (FEI 3006316363) after an inspection that ran Feb 7 – Dec 23, 2009. The investigators were Anna M. Brannen, Elizabeth L. Loreaux and Nicholas L. Paulin. Most observations concern quality system and production; the most-cited regulation is 21 CFR 211.25 (personnel qualifications).
At a glance
Quality system and production account for 7 of 10 observations.
Most cited: 21 CFR 211.25 (2×) · 211.192 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are…
- 02
Established laboratory control mechanisms are not documented at…
- 03
Written production and process control procedures are not followed in the execution of production…
- 04
In-process materials are not tested for quality and purity and approved or rejected by the quality…
This inspection in context
Anna M. Brannen
2 documents · 2009–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in India.
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 211.25
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Amylin Pharmaceuticals Inc.?
FDA listed 10 observations on this Form 483, mostly about quality system, production and laboratory controls. The most-cited regulation is 21 CFR 211.25 (personnel qualifications). The opening words of each observation are shown on this page.
Who inspected Amylin Pharmaceuticals Inc.?
Anna M. Brannen, Elizabeth L. Loreaux and Nicholas L. Paulin are named on this Form 483, for the inspection of Feb 7 – Dec 23, 2009. Each investigator has a profile showing what they cite most.
When was Amylin Pharmaceuticals Inc. inspected by FDA?
The inspection ran Feb 7 – Dec 23, 2009, and the Form 483 is dated December 23, 2009.
How do I get the full Form 483 for Amylin Pharmaceuticals Inc.?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.