Atlas

Form 483

Bacterin International, Inc. Form 483, 2011-08-10

FDA issued a Form 483 to Bacterin International, Inc. on 2011-08-10 with 1 public-safe observation.

483· Form 483 issued1 observation

Bacterin International, Inc. · Belgrade, United States · Issued August 10, 2011

Overview

  • 1 public-safe observation is available for this inspection.
  • 1 structured CFR citation is represented.
  • 2 investigators are tied to this Form 483.

Inspectional observations

Each observation cites the regulation FDA found the firm out of compliance with.

10 Aug 2011
21 CFR 1271.75(a)(1)

Risk factors, clinical evidence

Cited by Mark W Babbitt, Alexander M Kay

Inspected site

BIBacterin International, Inc.Belgrade, United States

Inspection team

MWMark W Babbitt
AMAlexander M Kay

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 1271.75(a)(1)Cited across public-safe Form 483 observations1x

Full 483 report

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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