Amylin Pharmaceuticals Inc.
Form 483 issued May 25, 2022 · West Chester, Ohio
- Inspection
- May 4 – May 25, 2022
- Observations
- 5
- Pages
- 6
- FEI number
- 3006316363
In short: On May 25, 2022, FDA issued a Form 483 with 5 observations to Amylin Pharmaceuticals Inc. in West Chester, Ohio (FEI 3006316363) after an inspection that ran May 4 – May 25, 2022. Most observations concern quality system and facilities & equipment.
At a glance
Quality system and facilities & equipment account for 3 of 5 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate…
- 02
Employees engaged in the manufacture, processing, packing and holding of a drug product lack the training…
- 03
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 04
Drug products failing to meet established standards, specifications and quality control…
This inspection in context
Questions about this 483
What did FDA find at Amylin Pharmaceuticals Inc.?
FDA listed 5 observations on this Form 483, mostly about quality system, facilities & equipment and laboratory controls. The opening words of each observation are shown on this page.
When was Amylin Pharmaceuticals Inc. inspected by FDA?
The inspection ran May 4 – May 25, 2022, and the Form 483 is dated May 25, 2022.
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.