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1116358

Person & Covey Inc — FEI 2011222

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
January 30, 2020
Fiscal Year
2020
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Glendale, CA (United States)

Facility

Other inspections at this facility

  • 1047199 (VAI Fri Apr 06 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 745733 (VAI Wed Sep 21 2011 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 673924 (OAI Fri Jul 23 2010 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
136121 CFR 211.100(a)Absence of Written Procedures
145021 CFR 211.113(a)Procedures for non-sterile drug products
186821 CFR 211.94(b)Protection from external factors
192721 CFR 211.166(b)Accelerated stability studies
195821 CFR 211.180(f)Responsible firm officials notified in writing
430321 CFR 211.67(b)Written procedures fail to include