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1163752

CooperSurgical, Inc. — FEI 1316626

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
March 4, 2022
Fiscal Year
2022
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
North Tonawanda, NY (United States)

Facility

Other inspections at this facility

  • 1098244 (VAI Thu Aug 01 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 872170 (VAI Fri Mar 21 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 839927 (NAI Fri Jun 28 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 782535 (VAI Wed May 23 2012 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 611764 (NAI Tue Sep 15 2009 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
202721 CFR 211.192Investigations of discrepancies, failures
360321 CFR 211.160(b)Scientifically sound laboratory controls
430321 CFR 211.67(b)Written procedures fail to include
438221 CFR 211.198(b)(2)Written record of complaint to include findings, follow-up
440221 CFR 211.192Written record of investigation incomplete