Perrigo New York, Inc.
Form 483 issued September 17, 2024 · Bronx, New York
- Inspection
- Sep 9 – Sep 17, 2024
- Observations
- 3
- Pages
- 4
- FEI number
- 2450054
In short: On September 17, 2024, FDA issued a Form 483 with 3 observations to Perrigo New York, Inc. in Bronx, New York (FEI 2450054) after an inspection that ran Sep 9 – Sep 17, 2024. Most observations concern quality system and laboratory controls.
At a glance
Quality system and laboratory controls account for 2 of 3 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 02
Laboratory records do not include complete data derived from all tests, examinations and assay necessary to…
- 03
Deviations from written production and process control procedures are…
This inspection in context
Questions about this 483
What did FDA find at Perrigo New York, Inc.?
FDA listed 3 observations on this Form 483, mostly about quality system, laboratory controls and production. The opening words of each observation are shown on this page.
When was Perrigo New York, Inc. inspected by FDA?
The inspection ran Sep 9 – Sep 17, 2024, and the Form 483 is dated September 17, 2024.
How do I get the full Form 483 for Perrigo New York, 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.