Atlas

Form 483

Amneal Pharmaceuticals of New York, LLC Form 483, 2019-01-30

FDA issued a Form 483 to Amneal Pharmaceuticals of New York, LLC on 2019-01-30 with 2 public-safe observations.

483· Form 483 issuedHuman Drugs2 observations

Amneal Pharmaceuticals of New York, LLC · Brookhaven, United States · Issued January 30, 2019

Overview

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

Inspectional observations

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

30 Jan 2019
21 CFR 211.22(d)

Procedures not in writing, fully followed

Cited by Patric C Klotzbuecher, Ruo H Xu

30 Jan 2019
21 CFR 211.22(d)

Procedures not in writing, fully followed

Cited by Patric C Klotzbuecher, Ruo H Xu

Inspected site

APAmneal Pharmaceuticals of New York, LLCBrookhaven, United States

Inspection team

PCPatric C Klotzbuecher
RHRuo H Xu

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.22(d)Cited across public-safe Form 483 observations2x

Full 483 report

Get the verbatim text of all 2 observations

Every observation in full, 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