675952

Access Bio, Inc. — FEI 3008474767

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
August 31, 2010
Fiscal Year
2010
Product Type
Devices
Project Area
Compliance: Devices
Location
Somerset, NJ (United States)

Citations

IDCFRDescription
315921 CFR 820.184DHR content
333121 CFR 820.181DMR - not or inadequately maintained
45421 CFR 820.40(a)Document review, approval by designated individual
48621 CFR 820.50(a)Evaluation of suppliers, contractors, etc., requirements
54121 CFR 820.70(c)Environmental control Lack of or inadequate procedures