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1195144

Packaging On Demand, Inc. — FEI 3004758248

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
January 13, 2023
Fiscal Year
2023
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
San Clemente, CA (United States)

Facility

Other inspections at this facility

  • 1250237 (VAI Fri Sep 27 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 967593 (VAI Fri Jan 08 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 945637 (VAI Fri Oct 16 2015 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
117721 CFR 211.63Equipment Design, Size and Location
126321 CFR 211.68(b)Computer control of master formula records
136121 CFR 211.100(a)Absence of Written Procedures
185121 CFR 211.84(e)Rejecting When Specifications Not Met
191221 CFR 211.166(a)Written program not followed
202621 CFR 211.192Quality control unit review of records
363221 CFR 211.170(b)Annual visual exams of drug products
431421 CFR 211.84(d)(2)Reports of Analysis (Components)
439121 CFR 211.180(e)(2)Items to cover on annual reviews