FDA Inspection 1169951 — Certified Laboratories LLC

Certified Laboratories LLC — FEI 3003838850

The FDA completed an inspection of Certified Laboratories LLC on May 20, 2022 in Carrollton, TX. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 4 citations were issued during this inspection. Product area: Drugs.

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
May 20, 2022
Fiscal Year
2022
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Carrollton, TX (United States)

Citations

IDCFRDescription
189021 CFR 211.165(e)Test methods
240121 CFR 211.194(a)(4)Complete Test Data
356521 CFR 211.58Buildings not maintained in good state of repair
357221 CFR 211.100(b)Procedure Deviations Recorded and Justified