Atlas

Form 483

Bacterin International, Inc. Form 483, 2013-08-02

FDA issued a Form 483 to Bacterin International, Inc. on 2013-08-02 with 2 public-safe observations.

483· Form 483 issuedBiologics2 observations

Bacterin International, Inc. · Belgrade, United States · Issued August 2, 2013

Overview

  • 2 public-safe observations are available for this inspection.
  • 2 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.

2 Aug 2013
21 CFR 1271.180(a)

Procedures to meet core CTGP

Cited by Julian C Hanson

2 Aug 2013
21 CFR 1271.190(d)(1)

Procedures for cleaning, sanitation

Cited by Julian C Hanson

Inspected site

BIBacterin International, Inc.Belgrade, United States

Inspection team

JCJulian C Hanson

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 1271.180(a)Cited across public-safe Form 483 observations1x
21 CFR 1271.190(d)(1)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 2 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