696428

Professional Disposables International, Inc. — FEI 2411192

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
October 21, 2010
Fiscal Year
2011
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Orangeburg, NY (United States)

Citations

IDCFRDescription
135821 CFR 211.100(b)SOPs not followed / documented
202721 CFR 211.192Investigations of discrepancies, failures
434021 CFR 211.142Written warehousing procedures established/followed