Form 483

Micro Measurement Laboratories, Inc. Form 483, 2013-12-19

FDA issued a Form 483 to Micro Measurement Laboratories, Inc. on 2013-12-19 with 3 public-safe observations.

483· Form 483 issuedHuman Drugs3 observations

Micro Measurement Laboratories, Inc. · Wheeling, United States · Issued December 19, 2013

Overview

  • 3 public-safe observations are available for this inspection.
  • 3 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.

19 Dec 2013
21 CFR 211.192

Written record of investigation incomplete

Cited by That Q Dang, Christopher D Leach

19 Dec 2013
21 CFR 820.22

Quality audits - auditor independence

Cited by That Q Dang, Christopher D Leach

19 Dec 2013
21 CFR 820.100(a)

Lack of or inadequate procedures

Cited by That Q Dang, Christopher D Leach

Inspected site

MMMicro Measurement Laboratories, Inc.Wheeling, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.192Cited across public-safe Form 483 observations1x
21 CFR 820.100(a)Cited across public-safe Form 483 observations1x
21 CFR 820.22Cited 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