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1261268

Medical Chemical Corporation — FEI 2013736

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
February 18, 2025
Fiscal Year
2025
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Torrance, CA (United States)

Facility

Other inspections at this facility

  • 1241801 (VAI Mon Jun 10 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1165578 (NAI Fri Mar 25 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1062302 (VAI Thu Aug 16 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 920513 (VAI Wed Feb 25 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 751813 (VAI Wed Oct 19 2011 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
136121 CFR 211.100(a)Absence of Written Procedures
184221 CFR 211.84(d)(1)Component identity verification
184321 CFR 211.84(d)(2)Component written specification
184421 CFR 211.84(d)(2)Establish reliability of supplier's C of A
189021 CFR 211.165(e)Test methods
201221 CFR 211.188(b)Batch production and Batch Control Record Requirements
202821 CFR 211.192Extent of discrepancy, failure investigations
240121 CFR 211.194(a)(4)Complete Test Data