FDA Inspection 1141007 — COLONIAL DAMES CO LTD

COLONIAL DAMES CO LTD — FEI 2011035

The FDA completed an inspection of COLONIAL DAMES CO LTD on April 29, 2021 in Commerce, CA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 3 citations were issued during this inspection. Product area: Drugs.

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
April 29, 2021
Fiscal Year
2021
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Commerce, CA (United States)

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
176721 CFR 211.137(a)Expiration date lacking
188321 CFR 211.165(a)Testing and release for distribution