Atlas

Form 483

HK Kolmar USA, LLC Form 483, 2014-03-04

FDA issued a Form 483 to HK Kolmar USA, LLC on 2014-03-04 with 6 public-safe observations.

483· Form 483 issuedHuman Drugs6 observations

HK Kolmar USA, LLC · Scott Township, United States · Issued March 4, 2014

Overview

  • 6 public-safe observations are available for this inspection.
  • 6 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.

4 Mar 2014
21 CFR 211.22(d)

Procedures not in writing, fully followed

Cited by James M Mason

4 Mar 2014
21 CFR 211.46(b)

Equipment for Environmental Control

Cited by James M Mason

4 Mar 2014
21 CFR 211.67(b)

Written procedures not established/followed

Cited by James M Mason

4 Mar 2014
21 CFR 211.84(c)(2)

Containers sampled so as to prevent contamination

Cited by James M Mason

4 Mar 2014
21 CFR 211.180(c)

Records not made readily available to FDA

Cited by James M Mason

Inspected site

HKHK Kolmar USA, LLCScott Township, United States

Inspection team

JMJames M Mason

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.180(c)Cited across public-safe Form 483 observations1x
21 CFR 211.192Cited across public-safe Form 483 observations1x
21 CFR 211.22(d)Cited across public-safe Form 483 observations1x
21 CFR 211.46(b)Cited across public-safe Form 483 observations1x
21 CFR 211.67(b)Cited across public-safe Form 483 observations1x
21 CFR 211.84(c)(2)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 6 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