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1250237

Packaging On Demand, Inc. — FEI 3004758248

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
September 27, 2024
Fiscal Year
2024
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
San Clemente, CA (United States)

Facility

Other inspections at this facility

  • 1195144 (OAI Fri Jan 13 2023 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
121521 CFR 211.67(b)Written procedures not established/followed
180321 CFR 211.84(b)Representative Samples Criteria
188321 CFR 211.165(a)Testing and release for distribution
197821 CFR 211.182Personnel dating/signing equipment log
200321 CFR 211.184(c)Individual inventory record
359121 CFR 211.110(b)In-process materials specifications
363021 CFR 211.170(b)Drug product reserve containers