Form 483

Aero All-Gas Company The Form 483, 2010-02-24

FDA issued a Form 483 to Aero All-Gas Company The on 2010-02-24 with 7 public-safe observations.

483· Form 483 issued7 observations

Aero All-Gas Company The · Hartford, United States · Issued February 24, 2010

Overview

  • 7 public-safe observations are available for this inspection.
  • 7 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.

24 Feb 2010
21 CFR 211.25(a)

Training--operations, GMPs, written procedures

Cited by Maya M Davis

24 Feb 2010
21 CFR 211.68(a)

Calibration/Inspection/Checking not done

Cited by Maya M Davis

24 Feb 2010
21 CFR 211.100(a)

Approval and review of procedures

Cited by Maya M Davis

24 Feb 2010
21 CFR 211.105(b)

Distinctive ID or code not recorded in batch record

Cited by Maya M Davis

24 Feb 2010
21 CFR 211.125(a)

Strict control not exercised over labeling issued

Cited by Maya M Davis

Inspected site

AAAero All-Gas Company TheHartford, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.100(a)Cited across public-safe Form 483 observations1x
21 CFR 211.105(b)Cited across public-safe Form 483 observations1x
21 CFR 211.125(a)Cited across public-safe Form 483 observations1x
21 CFR 211.194(a)(8)Cited across public-safe Form 483 observations1x
21 CFR 211.198(a)Cited across public-safe Form 483 observations1x
21 CFR 211.25(a)Cited across public-safe Form 483 observations1x
21 CFR 211.68(a)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 7 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