777958

SpecGx LLC — FEI 1317295

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
April 20, 2012
Fiscal Year
2012
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Hobart, NY (United States)

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
121321 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
144821 CFR 211.111Establishment of time limitations
355921 CFR 211.56(a)Sanitation--buildings not clean, free of infestation
360321 CFR 211.160(b)Scientifically sound laboratory controls
890721 CFR 314.81(b)(1)(ii)Contamination, chemical or physical change, deterioration