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976055

Private Label Partners, Inc. — FEI 3003350069

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
June 17, 2016
Fiscal Year
2016
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))
  • 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
119421 CFR 211.42(c)Defined areas of adequate size for operations
179021 CFR 211.80(b)Handling and Storage to Prevent Contamination
191221 CFR 211.166(a)Written program not followed
197521 CFR 211.182Written records kept in individual logs
201121 CFR 211.188(a)Accurate reproduction
201221 CFR 211.188(b)Batch production and Batch Control Record Requirements
355921 CFR 211.56(a)Sanitation--buildings not clean, free of infestation
357121 CFR 211.100(a)Changes to Procedures Not Reviewed, Approved
358321 CFR 211.110(a)Written in-process control procedures
457621 CFR 211.192No written record of investigation