Atlas

Form 483

Aero All-Gas Company The Form 483, 2017-10-19

FDA issued a Form 483 to Aero All-Gas Company The on 2017-10-19 with 4 public-safe observations.

483· Form 483 issuedHuman Drugs4 observations

Aero All-Gas Company The · Hartford, United States · Issued October 19, 2017

Overview

  • 4 public-safe observations are available for this inspection.
  • 4 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.

19 Oct 2017
21 CFR 211.125(a)

Strict control not exercised over labeling issued

Cited by Dien N Nguyen

19 Oct 2017
21 CFR 211.198(a)

Reporting of adverse drug experience to FDA

Cited by Dien N Nguyen

19 Oct 2017
21 CFR 211.22(d)

Procedures not in writing, fully followed

Cited by Dien N Nguyen

19 Oct 2017
21 CFR 211.68(a)

Calibration/Inspection/Checking not done

Cited by Dien N Nguyen

Inspected site

AAAero All-Gas Company TheHartford, United States

Inspection team

DNDien N Nguyen

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.125(a)Cited across public-safe Form 483 observations1x
21 CFR 211.198(a)Cited across public-safe Form 483 observations1x
21 CFR 211.22(d)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 4 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