Perrigo New York, Inc.
Form 483 issued January 22, 2019 · Bronx, New York
- Inspection
- Jan 10 – Jan 22, 2019
- Investigator
- Mindy M. Chou
- Observations
- 2
- Pages
- 4
- FEI number
- 2450054
In short: On January 22, 2019, FDA issued a Form 483 with 2 observations to Perrigo New York, Inc. in Bronx, New York (FEI 2450054) after an inspection that ran Jan 10 – Jan 22, 2019. The investigator was Mindy M. Chou. Most observations concern quality system and facilities & equipment; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Quality system and facilities & equipment account for 2 of 2 observations.
Most cited: 21 CFR 211.192 (1×) · 211.67(b) (1×)
What FDA observed
Preview: the opening words of each observation- 01
There is a failure to thoroughly review the failure of a batch or any of its…
- 02
Written procedures for cleaning and maintenance fail to include description in sufficient detail of methods…
This inspection in context
Mindy M. Chou
37 documents · 2015–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in New York.
The firmPerrigo New York, 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 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Perrigo New York, Inc.?
FDA listed 2 observations on this Form 483, mostly about quality system and facilities & equipment. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected Perrigo New York, Inc.?
Mindy M. Chou is named on this Form 483, for the inspection of Jan 10 – Jan 22, 2019. Each investigator has a profile showing what they cite most.
When was Perrigo New York, Inc. inspected by FDA?
The inspection ran Jan 10 – Jan 22, 2019, and the Form 483 is dated January 22, 2019.
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.