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697501

Reese Pharmaceutical Company — FEI 1518939

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
November 24, 2010
Fiscal Year
2011
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
110521 CFR 211.22(d)Procedures not in writing, fully followed
135821 CFR 211.100(b)SOPs not followed / documented
145421 CFR 211.115(a)Reprocessing procedures not written or followed
154021 CFR 211.125(a)Strict control not exercised over labeling issued
163021 CFR 211.130(b)Unlabeled filled containers controls
163221 CFR 211.130(c)Lot or control number assigned
172221 CFR 211.134(a)Correct labels during finishing operations
200421 CFR 211.184(d)Labeling: documentation of exam and review
200721 CFR 211.186(a)Signature and checking of records -- 2 persons
200921 CFR 211.188Prepared for each batch, include complete information
202621 CFR 211.192Quality control unit review of records
202721 CFR 211.192Investigations of discrepancies, failures
204421 CFR 211.196Distribution Record Requirements
430721 CFR 211.80(d)Status of Each Lot Identified
437221 CFR 211.188(b)(8)Labeling control records including specimens or copies
440121 CFR 211.186(b)(9)Complete instructions, procedures, specifications et. al.