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1169512

GCP Laboratories — FEI 1019058

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
May 13, 2022
Fiscal Year
2022
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Gulfport, MS (United States)

Facility

Other inspections at this facility

  • 1099910 (NAI Wed Aug 07 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1039235 (NAI Wed Jan 10 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 913182 (NAI Wed Feb 04 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 752460 (NAI Fri Nov 04 2011 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 634442 (VAI Wed Dec 09 2009 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
103321 CFR 211.22(a)Authority lacking to review records, investigate errors
116921 CFR 211.42(a)Buildings of Suitable Size, Construction, Location
121321 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
140921 CFR 211.42(c)(4)In-Process Material Area
145021 CFR 211.113(a)Procedures for non-sterile drug products
201221 CFR 211.188(b)Batch production and Batch Control Record Requirements
358521 CFR 211.110(a)Control procedures to monitor and validate performance