732884

A.I.G Technologies Inc. — FEI 3003511617

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
July 1, 2011
Fiscal Year
2011
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Deerfield Beach, FL (United States)

Citations

IDCFRDescription
111221 CFR 211.25(a)Training--operations, GMPs, written procedures
116321 CFR 211.28(b)Habits of good sanitation & health
122721 CFR 211.67(c)Cleaning/maintenance records not kept
136121 CFR 211.100(a)Absence of Written Procedures
145021 CFR 211.113(a)Procedures for non-sterile drug products
172521 CFR 211.134(c)Examinations documented
180121 CFR 211.84(a)Components withheld from use pending release
197821 CFR 211.182Personnel dating/signing equipment log
900121 CFR 211.22(a)Lack of quality control unit