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728705

Med-Dyne, Inc. — FEI 3002947950

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
June 15, 2011
Fiscal Year
2011
Product Type
Devices
Project Area
Compliance: Devices
Location
Louisville, KY (United States)

Facility

Other inspections at this facility

  • 1289796 (NAI Thu Nov 06 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1195952 (VAI Mon Jan 30 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1091481 (NAI Tue May 21 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 999363 (VAI Tue Nov 01 2016 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
232821 CFR 820.22Quality audits - auditor independence
313021 CFR 820.100(a)Lack of or inadequate procedures
331321 CFR 820.120(d)Records, DHR {see also 820.184(e)}
366921 CFR 820.20(c)Management review - defined interval, sufficient frequency
369621 CFR 820.100(b)Documentation
405921 CFR 820.22Quality Audits - defined intervals
407021 CFR 820.30(g)Design validation - documentation