Form 483

Micro Measurement Laboratories, Inc. Form 483, 2019-01-24

FDA issued a Form 483 to Micro Measurement Laboratories, Inc. on 2019-01-24 with 6 public-safe observations.

483· Form 483 issuedHuman Drugs6 observations

Micro Measurement Laboratories, Inc. · Wheeling, United States · Issued January 24, 2019

Overview

  • 6 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.

24 Jan 2019
21 CFR 211.160(b)(3)

Acceptance of drug products

Cited by Brian D Nicholson

24 Jan 2019
21 CFR 211.160(b)(3)

Acceptance of drug products

Cited by Brian D Nicholson

24 Jan 2019
21 CFR 211.194(a)(2)

Suitability of testing methods verified

Cited by Brian D Nicholson

24 Jan 2019
21 CFR 211.194(a)(2)

Suitability of testing methods verified

Cited by Brian D Nicholson

24 Jan 2019
21 CFR 211.22(d)

Procedures not in writing, fully followed

Cited by Brian D Nicholson

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 211.160(b)(3)Cited across public-safe Form 483 observations2x
21 CFR 211.194(a)(2)Cited across public-safe Form 483 observations2x
21 CFR 211.22(d)Cited across public-safe Form 483 observations2x

Source document

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PDF available

Form 483 source document

The source document is available to authorized Atlas users.

Full 483 report

Get the verbatim text of all 6 observations

The source PDF and 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