Atlas

Form 483

AJES Pharmaceuticals, LLC Form 483, 2013-07-11

FDA issued a Form 483 to AJES Pharmaceuticals, LLC on 2013-07-11 with 2 public-safe observations.

483· Form 483 issuedFoods & Cosmetics2 observations

AJES Pharmaceuticals, LLC · Copiague, United States · Issued July 11, 2013

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.

11 Jul 2013
21 CFR 111.27(b)

Instruments - calibration

Cited by Kwong P Lee

11 Jul 2013
21 CFR 111.430(a)

Packaging, labeling operations:originals, copies, electronic

Cited by Kwong P Lee

Inspected site

APAJES Pharmaceuticals, LLCCopiague, United States

Inspection team

KPKwong P Lee

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 111.27(b)Cited across public-safe Form 483 observations1x
21 CFR 111.430(a)Cited across public-safe Form 483 observations1x

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