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784467

Mission Pharmacal Company — FEI 3000204446

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
May 25, 2012
Fiscal Year
2012
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Boerne, TX (United States)

Facility

Other inspections at this facility

  • 1219105 (NAI Tue Jun 27 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1180935 (VAI Thu Sep 22 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1067651 (NAI Thu Sep 20 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1019109 (NAI Thu May 04 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 866629 (NAI Fri Feb 07 2014 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
202721 CFR 211.192Investigations of discrepancies, failures
358321 CFR 211.110(a)Written in-process control procedures
358521 CFR 211.110(a)Control procedures to monitor and validate performance
438621 CFR 211.198(b)Written complaint record to be maintained at facility
890721 CFR 314.81(b)(1)(ii)Contamination, chemical or physical change, deterioration