Atlas

Form 483

New Jersey Laboratories Form 483, 2026-05-12

FDA issued a Form 483 to New Jersey Laboratories on 2026-05-12 with 2 public-safe observations.

483· Form 483 issuedHuman Drugs2 observations

New Jersey Laboratories · New Brunswick, United States · Issued May 12, 2026

Overview

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

Inspectional observations

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

12 May 2026
21 CFR 211.194(a)(1)

Sample identification and other information

Cited by Frederick Razzaghi

12 May 2026
21 CFR 211.67(b)

Written procedures fail to include

Cited by Frederick Razzaghi

Inspected site

NJNew Jersey LaboratoriesNew Brunswick, United States

Inspection team

FRFrederick Razzaghi

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.194(a)(1)Cited across public-safe Form 483 observations1x
21 CFR 211.67(b)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 2 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