Amylin Pharmaceuticals Inc.
Form 483 issued August 9, 2019 · West Chester, Ohio
- Inspection
- Aug 5 – Aug 9, 2019
- Investigator
- Richard T. Riggie
- Observations
- 3
- Pages
- 5
- FEI number
- 3006316363
In short: On August 9, 2019, FDA issued a Form 483 with 3 observations to Amylin Pharmaceuticals Inc. in West Chester, Ohio (FEI 3006316363) after an inspection that ran Aug 5 – Aug 9, 2019. The investigator was Richard T. Riggie. Most observations concern production and quality system.
At a glance
2 of 3 observations on this 483 concern production.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Rejected in-process materials are not identified and controlled under a quarantine system to prevent their use…
- 02
Records do not include the disposition of rejected components, drug product…
- 03
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
This inspection in context
Richard T. Riggie
5 documents · 2019–2026
Cites 211.110 (sampling and testing of in-process materials and drug products) more than any other section. Most of their documents are for sites in Illinois.
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 211.110
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Amylin Pharmaceuticals Inc.?
FDA listed 3 observations on this Form 483, mostly about production and quality system. The opening words of each observation are shown on this page.
Who inspected Amylin Pharmaceuticals Inc.?
Richard T. Riggie is named on this Form 483, for the inspection of Aug 5 – Aug 9, 2019. Each investigator has a profile showing what they cite most.
When was Amylin Pharmaceuticals Inc. inspected by FDA?
The inspection ran Aug 5 – Aug 9, 2019, and the Form 483 is dated August 9, 2019.
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.