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Form 483

Microbac Laboratories, Inc. Form 483, 2021-05-24

FDA issued a Form 483 to Microbac Laboratories, Inc. on 2021-05-24 with 1 public-safe observation.

483· Form 483 issuedHuman Drugs1 observation

Microbac Laboratories, Inc. · Sterling, United States · Issued May 24, 2021

Overview

  • 1 public-safe observation is available for this inspection.
  • 1 structured CFR citation is 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 May 2021
21 CFR 211.22(d)

Procedures not in writing, fully followed

Cited by Jaison J Eapen

Inspected site

MLMicrobac Laboratories, Inc.Sterling, United States

Inspection team

JJJaison J Eapen

Cited regulations

CFR citations associated with this Form 483.

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

Source document

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Form 483 source document

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Full 483 report

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  • 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