888588

Pharbest Pharmaceuticals, Inc. — FEI 3005382247

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
July 11, 2014
Fiscal Year
2014
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Farmingdale, NY (United States)

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
135821 CFR 211.100(b)SOPs not followed / documented
136121 CFR 211.100(a)Absence of Written Procedures
354521 CFR 211.44Adequate lighting not provided
434021 CFR 211.142Written warehousing procedures established/followed
440221 CFR 211.192Written record of investigation incomplete