Form 483

AWERS Inc Form 483, 2021-12-17

FDA issued a Form 483 to AWERS Inc on 2021-12-17 with 3 public-safe observations.

483· Form 483 issuedFoods & Cosmetics3 observations

AWERS Inc · Bellevue, United States · Issued December 17, 2021

Overview

  • 3 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.

17 Dec 2021
21 CFR 117.4

Training of employees and records

Cited by Lisa A Bowden

17 Dec 2021
21 CFR 123.6(b)

HACCP plan implementation

Cited by Lisa A Bowden

17 Dec 2021
21 CFR 123.8(a)(3)

Verification - record review - frequency

Cited by Lisa A Bowden

Inspected site

AIAWERS IncBellevue, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 117.4Cited across public-safe Form 483 observations1x
21 CFR 123.6(b)Cited across public-safe Form 483 observations1x
21 CFR 123.8(a)(3)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 3 observations

The full inspection record, as Atlas holds it, 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