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Form 483

Biomat USA Inc (Birmingham Location #2) Form 483, 2012-03-30

FDA issued a Form 483 to Biomat USA Inc (Birmingham Location #2) on 2012-03-30 with 1 public-safe observation.

483· Form 483 issued1 observation

Biomat USA Inc (Birmingham Location #2) · Birmingham, United States · Issued March 30, 2012

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.

30 Mar 2012
21 CFR 606.160(a)(1)

Concurrent documentation

Cited by Danielle M Maddox

Inspected site

BUBiomat USA Inc (Birmingham Location #2)Birmingham, United States

Inspection team

DMDanielle M Maddox

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 606.160(a)(1)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 1 observation

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