1026101

Surgical Appliance Industries Inc — FEI 1511629

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
September 22, 2017
Fiscal Year
2017
Product Type
Devices
Project Area
Compliance: Devices
Location
Cincinnati, OH (United States)

Citations

IDCFRDescription
312121 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
313021 CFR 820.100(a)Lack of or inadequate procedures
315921 CFR 820.184DHR content
328221 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
343321 CFR 820.75(c)Process changes - review, evaluation and revalidation
47921 CFR 820.50Purchasing controls, Lack of or inadequate procedures