Atlas

Form 483

James Hook & Company, LLC Form 483, 2011-11-23

FDA issued a Form 483 to James Hook & Company, LLC on 2011-11-23 with 3 public-safe observations.

483· Form 483 issued3 observations

James Hook & Company, LLC · Boston, United States · Issued November 23, 2011

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.

23 Nov 2011
21 CFR 123.6(c)(2)

Critical control points

Cited by John P Shelton

23 Nov 2011
21 CFR 123.8(a)(3)(i)

Monitoring record review adequacy

Cited by John P Shelton

23 Nov 2011
21 CFR 123.11(b)

Sanitation monitoring

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)(2)Cited across public-safe Form 483 observations1x
21 CFR 123.8(a)(3)(i)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 3 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