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Form 483

James Hook & Company, LLC Form 483, 2021-12-16

FDA issued a Form 483 to James Hook & Company, LLC on 2021-12-16 with 2 public-safe observations.

483· Form 483 issuedFoods & Cosmetics2 observations

James Hook & Company, LLC · Boston, United States · Issued December 16, 2021

Overview

  • 2 public-safe observations are available for this inspection.
  • 2 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.

16 Dec 2021
21 CFR 123.11(b)

Sanitation monitoring documentation

Cited by John P Shelton

16 Dec 2021
21 CFR 123.6(c)(6)

Verification procedures - none/frequency

Cited by John P Shelton

Inspected site

JHJames Hook & Company, LLCBoston, United States

Inspection team

JPJohn P Shelton

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 123.11(b)Cited across public-safe Form 483 observations1x
21 CFR 123.6(c)(6)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