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813306

Prime Enterprises LLC dba Prime Matter Labs — FEI 1036626

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
January 3, 2013
Fiscal Year
2013
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Hialeah, FL (United States)

Facility

Other inspections at this facility

  • 1283388 (NAI Wed Aug 13 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1216813 (VAI Fri Sep 01 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1057443 (NAI Wed Jun 13 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 931771 (VAI Mon Jun 08 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 596457 (VAI Mon Jul 13 2009 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
111221 CFR 211.25(a)Training--operations, GMPs, written procedures
116921 CFR 211.42(a)Buildings of Suitable Size, Construction, Location
121321 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
144821 CFR 211.111Establishment of time limitations
188521 CFR 211.165(b)Microbiological testing
189021 CFR 211.165(e)Test methods
189121 CFR 211.165(f)Failing drug products not rejected
191221 CFR 211.166(a)Written program not followed
194321 CFR 211.180(e)(1)Review of representative number of batches
202721 CFR 211.192Investigations of discrepancies, failures
358521 CFR 211.110(a)Control procedures to monitor and validate performance
360321 CFR 211.160(b)Scientifically sound laboratory controls