Form 483

Holmes Produce, L.L.C. Form 483, 2016-10-06

FDA issued a Form 483 to Holmes Produce, L.L.C. on 2016-10-06 with 4 public-safe observations.

483· Form 483 issuedFoods & Cosmetics4 observations

Holmes Produce, L.L.C. · Wichita, United States · Issued October 6, 2016

Overview

  • 4 public-safe observations are available for this inspection.
  • 4 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.

6 Oct 2016
21 CFR 114.80(a)

Quality control procedures

Cited by Kevin A Beavers, Nicole C Mayfield

6 Oct 2016
21 CFR 114.80(a)(1)

Scheduled process

Cited by Kevin A Beavers, Nicole C Mayfield

6 Oct 2016
21 CFR 110.10(b)(5)

Glove condition

Cited by Kevin A Beavers, Nicole C Mayfield

6 Oct 2016
21 CFR 114.89

Process deviation

Cited by Kevin A Beavers, Nicole C Mayfield

Inspected site

HPHolmes Produce, L.L.C.Wichita, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 110.10(b)(5)Cited across public-safe Form 483 observations1x
21 CFR 114.80(a)Cited across public-safe Form 483 observations1x
21 CFR 114.80(a)(1)Cited across public-safe Form 483 observations1x
21 CFR 114.89Cited across public-safe Form 483 observations1x

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