Atlas

Form 483

Perrigo New York, Inc. Form 483, 2026-05-08

FDA issued a Form 483 to Perrigo New York, Inc. on 2026-05-08 with 4 public-safe observations.

483· Form 483 issuedHuman Drugs4 observations

Perrigo New York, Inc. · Bronx, United States · Issued May 8, 2026

Overview

  • 4 public-safe observations are available for this inspection.
  • 4 structured CFR citations are represented.
  • 2 investigators are tied to this Form 483.

Inspectional observations

Each observation cites the regulation FDA found the firm out of compliance with.

8 May 2026
21 CFR 211.42(c)(5)

Mfg / Processing Operations Area

Cited by Edmund F Mrak, Ifechimere I Okafor

8 May 2026
21 CFR 211.46(b)

Equipment for Environmental Control

Cited by Edmund F Mrak, Ifechimere I Okafor

8 May 2026
21 CFR 211.58

Buildings not maintained in good state of repair

Cited by Edmund F Mrak, Ifechimere I Okafor

8 May 2026
21 CFR 211.67(a)

Cleaning / Sanitizing / Maintenance

Cited by Edmund F Mrak, Ifechimere I Okafor

Inspected site

PNPerrigo New York, Inc.Bronx, United States

Inspection team

EFEdmund F Mrak
IIIfechimere I Okafor

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.42(c)(5)Cited across public-safe Form 483 observations1x
21 CFR 211.46(b)Cited across public-safe Form 483 observations1x
21 CFR 211.58Cited across public-safe Form 483 observations1x
21 CFR 211.67(a)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 4 observations

The full inspection record, as Atlas holds it, so your team sees exactly what was cited and how it was answered.

  • The site's full inspection history around this Form 483
  • Whether these citations escalated to a warning letter
  • The investigators involved and the citations they repeat elsewhere