Atlas

Form 483

Aero-Med LLC Form 483, 2018-12-21

FDA issued a Form 483 to Aero-Med LLC on 2018-12-21 with 4 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health4 observations

Aero-Med LLC · East Hartford, United States · Issued December 21, 2018

Overview

  • 4 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.

21 Dec 2018
21 CFR 820.181

DMR - not or inadequately maintained

Cited by Jeffrey J Thibodeau

21 Dec 2018
21 CFR 820.181

DMR - not or inadequately maintained

Cited by Jeffrey J Thibodeau

21 Dec 2018
21 CFR 820.184(f)

DHR - UDI not included

Cited by Jeffrey J Thibodeau

21 Dec 2018
21 CFR 820.184(f)

DHR - UDI not included

Cited by Jeffrey J Thibodeau

Inspected site

ALAero-Med LLCEast Hartford, United States

Inspection team

JJJeffrey J Thibodeau

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 820.181Cited across public-safe Form 483 observations2x
21 CFR 820.184(f)Cited across public-safe Form 483 observations2x

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