Atlas

Form 483

Combe Products, Inc. Form 483, 2009-11-30

FDA issued a Form 483 to Combe Products, Inc. on 2009-11-30 with 3 public-safe observations.

483· Form 483 issued3 observations

Combe Products, Inc. · Naguabo, United States · Issued November 30, 2009

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.

30 Nov 2009
21 CFR 211.22(d)

Procedures not in writing, fully followed

Cited by Jorge L Lajara

30 Nov 2009
21 CFR 211.58

Buildings not maintained in good state of repair

Cited by Jorge L Lajara

30 Nov 2009
21 CFR 211.198(a)

Complaint Handling Procedure

Cited by Jorge L Lajara

Inspected site

CPCombe Products, Inc.Naguabo, United States

Inspection team

JLJorge L Lajara

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.198(a)Cited across public-safe Form 483 observations1x
21 CFR 211.22(d)Cited across public-safe Form 483 observations1x
21 CFR 211.58Cited 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