Atlas

Form 483

Axiosonic LLC Form 483, 2018-12-06

FDA issued a Form 483 to Axiosonic LLC on 2018-12-06 with 6 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health6 observations

Axiosonic LLC · Effingham, United States · Issued December 6, 2018

Overview

  • 6 public-safe observations are available for this inspection.
  • 3 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.

6 Dec 2018
21 CFR 820.100(a)

Lack of or inadequate procedures

Cited by Maksim A Levenchuk

6 Dec 2018
21 CFR 820.100(a)

Lack of or inadequate procedures

Cited by Maksim A Levenchuk

6 Dec 2018
21 CFR 820.25(b)

Training - Lack of or inadequate procedures

Cited by Maksim A Levenchuk

6 Dec 2018
21 CFR 820.25(b)

Training - Lack of or inadequate procedures

Cited by Maksim A Levenchuk

6 Dec 2018
21 CFR 820.90(a)

Nonconforming product, Lack of or inadequate procedures

Cited by Maksim A Levenchuk

Inspected site

ALAxiosonic LLCEffingham, United States

Inspection team

MAMaksim A Levenchuk

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 820.100(a)Cited across public-safe Form 483 observations2x
21 CFR 820.25(b)Cited across public-safe Form 483 observations2x
21 CFR 820.90(a)Cited across public-safe Form 483 observations2x

Full 483 report

Get the verbatim text of all 6 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