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1152419

Pharmco Laboratories Inc. — FEI 1048788

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
September 22, 2021
Fiscal Year
2021
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Titusville, FL (United States)

Facility

Other inspections at this facility

  • 1231002 (VAI Thu Mar 20 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1096135 (NAI Fri Jun 28 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 951092 (OAI Mon Nov 30 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 787476 (VAI Thu Jun 21 2012 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
117721 CFR 211.63Equipment Design, Size and Location
121921 CFR 211.67(b)(2)Cleaning SOPs/schedules
202621 CFR 211.192Quality control unit review of records
202721 CFR 211.192Investigations of discrepancies, failures
356521 CFR 211.58Buildings not maintained in good state of repair
358521 CFR 211.110(a)Control procedures to monitor and validate performance
360321 CFR 211.160(b)Scientifically sound laboratory controls
363021 CFR 211.170(b)Drug product reserve containers
363221 CFR 211.170(b)Annual visual exams of drug products