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1146202

CooperSurgical, Inc. — FEI 1216677

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
July 15, 2021
Fiscal Year
2021
Product Type
Devices
Project Area
Compliance: Devices
Location
Trumbull, CT (United States)

Facility

Other inspections at this facility

  • 1236656 (VAI Tue May 21 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1209056 (NAI Tue May 16 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1042445 (NAI Thu Dec 07 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1007880 (VAI Tue Mar 28 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 965134 (NAI Thu Mar 31 2016 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
328621 CFR 820.90(b)(1)Procedures for product review,disposition lack of/inadequate
331221 CFR 820.120(d)Mixups
54121 CFR 820.70(c)Environmental control Lack of or inadequate procedures
73221 CFR 803.50(a)(2)Individual Report of Malfunction