Home / Inspections / 774391

774391

Private Label Partners, Inc. — FEI 3003350069

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
March 14, 2012
Fiscal Year
2012
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Santa Ana, CA (United States)

Facility

Other inspections at this facility

  • 1258639 (OAI Fri Jan 17 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 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))
  • 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
136121 CFR 211.100(a)Absence of Written Procedures
188321 CFR 211.165(a)Testing and release for distribution
191221 CFR 211.166(a)Written program not followed
197521 CFR 211.182Written records kept in individual logs
357121 CFR 211.100(a)Changes to Procedures Not Reviewed, Approved
360321 CFR 211.160(b)Scientifically sound laboratory controls
432521 CFR 211.110(a)Control procedures fail to include the following
437021 CFR 211.188(b)(10)Records of any sampling performed