1014535

Biofilm, Inc. — FEI 2025771

Inspection Details

Classification
No Action Indicated (NAI) (NAI)
End Date
May 25, 2017
Fiscal Year
2017
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Vista, CA (United States)

Citations

IDCFRDescription
310221 CFR 820.30(h)Design transfer - Lack of or inadequate procedures
319221 CFR 820.30(g)Design validation - user needs and intended uses
369621 CFR 820.100(b)Documentation
41921 CFR 820.20(b)Lack of or inadequate organizational structure