Home / Inspections / 1047199

1047199

Person & Covey Inc — FEI 2011222

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
April 6, 2018
Fiscal Year
2018
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Glendale, CA (United States)

Facility

Other inspections at this facility

  • 1116358 (VAI Thu Jan 30 2020 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
104921 CFR 211.22(a)Approve or reject components, products
108621 CFR 211.22(b)Adequate lab facilities not available
117721 CFR 211.63Equipment Design, Size and Location
121521 CFR 211.67(b)Written procedures not established/followed
184421 CFR 211.84(d)(2)Establish reliability of supplier's C of A
194221 CFR 211.180(e)Records reviewed annually
202721 CFR 211.192Investigations of discrepancies, failures
241921 CFR 211.198(a)Complaint Handling Procedure
261921 CFR 211.198(b)(2)Complaint Investigation/Follow-Up Findings
358521 CFR 211.110(a)Control procedures to monitor and validate performance