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749702

Professional Disposables International, Inc. — FEI 2411192

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
October 18, 2011
Fiscal Year
2012
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Orangeburg, NY (United States)

Facility

Other inspections at this facility

  • 1236000 (NAI Fri Sep 19 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1146961 (OAI Wed Jun 23 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1040815 (VAI Fri Dec 01 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 951891 (VAI Wed Dec 09 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 838349 (NAI Thu Jun 13 2013 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
111121 CFR 211.25(a)Training , Education , Experience overall
121521 CFR 211.67(b)Written procedures not established/followed
181021 CFR 211.160(a)Lab controls established, including changes
191721 CFR 211.166(a)(1)Sample size - test intervals
193221 CFR 211.167(a)Sterility/pyrogen-free testing
202721 CFR 211.192Investigations of discrepancies, failures
362921 CFR 211.170(b)Reserve samples identified, representative, stored
438921 CFR 211.198(a)Procedures to be written and followed