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786642

Waters Medical Systems, LLC — FEI 2123774

Inspection Details

Classification
No Action Indicated (NAI) (NAI)
End Date
June 15, 2012
Fiscal Year
2012
Product Type
Devices
Project Area
Compliance: Devices
Location
Rochester, MN (United States)

Facility

Other inspections at this facility

  • 1247045 (NAI Wed Aug 14 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1008553 (NAI Thu Apr 20 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 583641 (NAI Wed May 13 2009 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
1471921 CFR 820.30(h)Incorrect translation to production specifications
243021 CFR 820.30(b)Design plans - Lack of or inadequate
405921 CFR 820.22Quality Audits - defined intervals