945549

Miami Fat Supply, Inc — FEI 3008872140

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
October 14, 2015
Fiscal Year
2016
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
Fruitland Park, FL (United States)

Citations

IDCFRDescription
1471321 CFR 820.198(a)Lack of or inadequate complaint procedures
232721 CFR 820.22Quality audits - Lack of or inadequate procedures
310321 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
310421 CFR 820.30(j)Design history file
312521 CFR 820.80(d)Lack of or inadequate final acceptance procedures
313021 CFR 820.100(a)Lack of or inadequate procedures
47921 CFR 820.50Purchasing controls, Lack of or inadequate procedures
54621 CFR 820.75(a)Lack of or inadequate process validation
63021 CFR 803.17Lack of Written MDR Procedures