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1258639

Private Label Partners, Inc. — FEI 3003350069

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
January 17, 2025
Fiscal Year
2025
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Santa Ana, CA (United States)

Facility

Other inspections at this facility

  • 1102451 (VAI Fri Sep 13 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 976055 (VAI Fri Jun 17 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 774391 (VAI Wed Mar 14 2012 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 711959 (VAI Tue Feb 08 2011 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 671675 (VAI Tue Jul 13 2010 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
183321 CFR 211.84(d)(1)Identity Testing of Each Component
184321 CFR 211.84(d)(2)Component written specification
188321 CFR 211.165(a)Testing and release for distribution
191221 CFR 211.166(a)Written program not followed
200921 CFR 211.188Prepared for each batch, include complete information
202721 CFR 211.192Investigations of discrepancies, failures
360321 CFR 211.160(b)Scientifically sound laboratory controls