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821943

Escalon Medical Corp. — FEI 2183477

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
March 7, 2013
Fiscal Year
2013
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
New Berlin, WI (United States)

Facility

Other inspections at this facility

  • 1277791 (NAI Tue Aug 05 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1111063 (VAI Mon Nov 25 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 660581 (NAI Mon Apr 12 2010 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
1471321 CFR 820.198(a)Lack of or inadequate complaint procedures
232821 CFR 820.22Quality audits - auditor independence
235021 CFR 820.25(b)Training - Lack of or inadequate procedures
311921 CFR 820.75(b)Lack/Inad procedure-Monitoring/Control of Validated Proces
312121 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
313021 CFR 820.100(a)Lack of or inadequate procedures
54121 CFR 820.70(c)Environmental control Lack of or inadequate procedures