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1120409

McKenna Labs Inc — FEI 3003449422

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
March 5, 2020
Fiscal Year
2020
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Fullerton, CA (United States)

Facility

Other inspections at this facility

  • 1261255 (VAI Thu Feb 13 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1016911 (VAI Wed Jul 05 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 702867 (NAI Tue Dec 21 2010 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 541848 (VAI Wed Oct 15 2008 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
111121 CFR 211.25(a)Training , Education , Experience overall
201221 CFR 211.188(b)Batch production and Batch Control Record Requirements
440121 CFR 211.186(b)(9)Complete instructions, procedures, specifications et. al.
440921 CFR 211.194(a)(4)Data secured in course of each test