FDA Inspection 646088 — Coats Aloe International, Inc.

Coats Aloe International, Inc. — FEI 3001451809

The FDA completed an inspection of Coats Aloe International, Inc. on January 15, 2010 in Dallas, TX. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Drugs.

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
January 15, 2010
Fiscal Year
2010
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Dallas, TX (United States)

Citations

IDCFRDescription
176721 CFR 211.137(a)Expiration date lacking
202721 CFR 211.192Investigations of discrepancies, failures