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758639

Reese Pharmaceutical Company — FEI 1518939

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
January 11, 2012
Fiscal Year
2012
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Cleveland, OH (United States)

Facility

Other inspections at this facility

  • 1287906 (NAI Thu Sep 25 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1160702 (NAI Thu Dec 09 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1160701 (NAI Wed Dec 08 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1017672 (NAI Mon Jun 05 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1012578 (NAI Tue Apr 25 2017 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
135821 CFR 211.100(b)SOPs not followed / documented
154021 CFR 211.125(a)Strict control not exercised over labeling issued
194321 CFR 211.180(e)(1)Review of representative number of batches
437421 CFR 211.188(b)(6)Inspection of packaging and labeling area
440121 CFR 211.186(b)(9)Complete instructions, procedures, specifications et. al.