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Form 483

Amneal Pharmaceuticals of New York, LLC Form 483, 2014-05-16

FDA issued a Form 483 to Amneal Pharmaceuticals of New York, LLC on 2014-05-16 with 2 public-safe observations.

483· Form 483 issuedHuman Drugs2 observations

Amneal Pharmaceuticals of New York, LLC · Brookhaven, United States · Issued May 16, 2014

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.

16 May 2014
21 CFR 211.22(d)

Procedures not in writing, fully followed

Cited by Robert C Horan

16 May 2014
21 CFR 211.160(b)

Scientifically sound laboratory controls

Cited by Robert C Horan

Inspected site

APAmneal Pharmaceuticals of New York, LLCBrookhaven, United States

Inspection team

RCRobert C Horan

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.160(b)Cited across public-safe Form 483 observations1x
21 CFR 211.22(d)Cited across public-safe Form 483 observations1x

Source document

PDF
PDF available

Form 483 source document

The source document is available to authorized Atlas users.

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Full 483 report

Get the verbatim text of all 2 observations

The source PDF and 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