Form 483

Woolery Enterprises Inc. dba Will's Fresh Foods Form 483, 2018-11-02

FDA issued a Form 483 to Woolery Enterprises Inc. dba Will's Fresh Foods on 2018-11-02 with 5 public-safe observations.

483· Form 483 issuedFoods & Cosmetics5 observations

Woolery Enterprises Inc. dba Will's Fresh Foods · San Leandro, United States · Issued November 2, 2018

Overview

  • 5 public-safe observations are available for this inspection.
  • 5 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.

2 Nov 2018
21 CFR 123.6(c)(4)

Monitoring - adequacy

Cited by Jennifer Crumb

2 Nov 2018
21 CFR 123.6(c)(6)

Verification procedures - adequacy

Cited by Jennifer Crumb

2 Nov 2018
21 CFR 123.6(c)(7)

Records system

Cited by Jennifer Crumb

2 Nov 2018
21 CFR 123.6(d)

Signed and dated

Cited by Jennifer Crumb

2 Nov 2018
21 CFR 123.8(a)(3)

Verification - record review - frequency

Cited by Jennifer Crumb

Inspected site

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 123.6(c)(4)Cited across public-safe Form 483 observations1x
21 CFR 123.6(c)(6)Cited across public-safe Form 483 observations1x
21 CFR 123.6(c)(7)Cited across public-safe Form 483 observations1x
21 CFR 123.6(d)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 5 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