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1031539

Dextrum Laboratories — FEI 3003092372

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
November 17, 2017
Fiscal Year
2018
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Miami, FL (United States)

Facility

Other inspections at this facility

  • 1249319 (OAI Thu Aug 29 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1210295 (OAI Tue Jul 18 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1192929 (VAI Fri Dec 16 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 965268 (VAI Fri Feb 12 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 790155 (NAI Tue Jul 10 2012 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
121321 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
121521 CFR 211.67(b)Written procedures not established/followed
125621 CFR 211.68(b)Backup file not maintained
184921 CFR 211.84(d)(6)Objectionable microbiological contamination
203121 CFR 211.194(a)Complete test data included in records
360321 CFR 211.160(b)Scientifically sound laboratory controls
434521 CFR 211.160(b)(1)Samples (various types) representative, identified properly