Perrigo New York, Inc.
Form 483 issued May 8, 2026 · Bronx, New York
- Inspection
- May 4 – May 8, 2026
- Investigators
- Edmund F. Mrak· Ifechimere I. Okafor
- Observations
- 3
- Pages
- 5
- FEI number
- 2450054
In short: On May 8, 2026, FDA issued a Form 483 with 3 observations to Perrigo New York, Inc. in Bronx, New York (FEI 2450054) after an inspection that ran May 4 – May 8, 2026. The investigators were Edmund F. Mrak and Ifechimere I. Okafor. Most observations concern facilities & equipment; the most-cited regulation is 21 CFR 211.46 (ventilation, air filtration, air heating and cooling).
At a glance
2 of 2 observations on this 483 concern facilities & equipment.
Most cited: 21 CFR 211.46(b) (1×) · 211.42(c)(5) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Equipment for adequate control over air pressure is not provided when appropriate for the manufacture, processing…
- 02
Separate or defined areas to prevent contamination or mix-ups are deficient regarding the…
This inspection in context
Edmund F. Mrak
30 documents · 2010–2026
Cites 211.42 (design and construction features) 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 211.46(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Perrigo New York, Inc.?
FDA listed 3 observations on this Form 483, mostly about facilities & equipment. The most-cited regulation is 21 CFR 211.46 (ventilation, air filtration, air heating and cooling). The opening words of each observation are shown on this page.
Who inspected Perrigo New York, Inc.?
Edmund F. Mrak and Ifechimere I. Okafor are named on this Form 483, for the inspection of May 4 – May 8, 2026. Each investigator has a profile showing what they cite most.
When was Perrigo New York, Inc. inspected by FDA?
The inspection ran May 4 – May 8, 2026, and the Form 483 is dated May 8, 2026.
How do I get the full Form 483 for Perrigo New York, Inc.?
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