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696608

Biomat USA Inc. — FEI 3004498724

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
November 23, 2010
Fiscal Year
2011
Product Type
Biologics
Project Area
Blood and Blood Products
Location
Whitehall, OH (United States)

Facility

Other inspections at this facility

  • 1152233 (NAI Fri Aug 27 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1001544 (NAI Fri Feb 24 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 915356 (NAI Thu Feb 26 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 812172 (NAI Fri Jan 04 2013 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
1220321 CFR 606.170(a)Adverse Reaction- Reports of Investigations
1503021 CFR 606.60(b)Equipment calibration frequency
15421 CFR 606.160(a)(1)Concurrent documentation
324821 CFR 640.63(a)Determining donor suitability
325821 CFR 640.63(d)Unreliable answers
33321 CFR 640.64(e)Prevention of contamination
7621 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
922521 CFR 606.171Biological product deviation report
924121 CFR 630.40(a)Supplemental results
924321 CFR 630.40(a)Notification
9821 CFR 606.100(c)Thorough investigations