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1216813

Prime Enterprises LLC dba Prime Matter Labs — FEI 1036626

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
September 1, 2023
Fiscal Year
2023
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))
  • 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))
  • 813306 (VAI Thu Jan 03 2013 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
136121 CFR 211.100(a)Absence of Written Procedures
145621 CFR 211.115(b)Reprocessing/quality control unit
356521 CFR 211.58Buildings not maintained in good state of repair
360321 CFR 211.160(b)Scientifically sound laboratory controls
457621 CFR 211.192No written record of investigation