Home / Inspections / 1246567

1246567

AJENAT PHARMACEUTICALS LLC — FEI 3033007964

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
August 16, 2024
Fiscal Year
2024
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Largo, FL (United States)

Facility

Other inspections at this facility

  • 1262754 (NAI Fri Feb 07 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1187488 (NAI Fri Nov 04 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1156749 (VAI Mon Nov 15 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1093582 (NAI Fri May 24 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1042674 (VAI Thu Mar 01 2018 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
143321 CFR 211.42(c)(10)(iii)Air Supply
188521 CFR 211.165(b)Microbiological testing
193821 CFR 211.167(c)Controlled release dosage form testing
22779FDCA 503B(b)(2)(A)All inclusive product report, not submitted
22787FDCA 503B(a)(10)(A)Drug product labels, fails to include
360321 CFR 211.160(b)Scientifically sound laboratory controls