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544577

Professional Disposables International, Inc. — FEI 2411192

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
October 29, 2008
Fiscal Year
2009
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
194321 CFR 211.180(e)(1)Review of representative number of batches
202721 CFR 211.192Investigations of discrepancies, failures
360321 CFR 211.160(b)Scientifically sound laboratory controls
439921 CFR 211.186(b)(7)Theoretical yield statement including percentages