Perrigo New York, Inc.
Form 483 issued October 24, 2022 · Bronx, New York
- Inspection
- Oct 19 – Oct 24, 2022
- Investigator
- Kwong P. Lee
- Observations
- 1
- Pages
- 3
- FEI number
- 2450054
In short: On October 24, 2022, FDA issued a Form 483 with 1 observation to Perrigo New York, Inc. in Bronx, New York (FEI 2450054) after an inspection that ran Oct 19 – Oct 24, 2022. The investigator was Kwong P. Lee. Most observations concern production & process controls; the most-cited regulation is 21 CFR 820.60 (identification).
At a glance
1 of 1 observations on this 483 concern production & process controls.
Most cited: 21 CFR 820.60 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures for identifying product during all stages of receipt, production, distribution, and installation have…
This inspection in context
Kwong P. Lee
12 documents · 2015–2026
Cites 820.30(c) (design controls) 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 820.60
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Perrigo New York, Inc.?
FDA listed 1 observation on this Form 483, mostly about production & process controls. The most-cited regulation is 21 CFR 820.60 (identification). The opening words of each observation are shown on this page.
Who inspected Perrigo New York, Inc.?
Kwong P. Lee is named on this Form 483, for the inspection of Oct 19 – Oct 24, 2022. Each investigator has a profile showing what they cite most.
When was Perrigo New York, Inc. inspected by FDA?
The inspection ran Oct 19 – Oct 24, 2022, and the Form 483 is dated October 24, 2022.
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.