Atlas

Form 483

Jasper Wyman and Son Hancock Form 483, 2022-08-25

FDA issued a Form 483 to Jasper Wyman and Son Hancock on 2022-08-25 with 2 public-safe observations.

483· Form 483 issuedFoods & Cosmetics2 observations

Jasper Wyman and Son Hancock · Hancock, United States · Issued August 25, 2022

Overview

  • 2 public-safe observations are available for this inspection.
  • 2 structured CFR citations are represented.
  • 2 investigators are tied to this Form 483.

Inspectional observations

Each observation cites the regulation FDA found the firm out of compliance with.

25 Aug 2022
21 CFR 117.135(c)(1)

Process preventive controls - Appropriate (Adequate)

Cited by Clinton V Giustra, Gerard D Difiore

25 Aug 2022
21 CFR 117.160(a)

Process controls - Validation

Cited by Clinton V Giustra, Gerard D Difiore

Inspected site

JWJasper Wyman and Son HancockHancock, United States

Inspection team

CVClinton V Giustra
GDGerard D Difiore

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 117.135(c)(1)Cited across public-safe Form 483 observations1x
21 CFR 117.160(a)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 2 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