FDA Inspection 1178487 — SwedencareUSA, Inc.

SwedencareUSA, Inc. — FEI 3012933424

The FDA completed an inspection of SwedencareUSA, Inc. on August 30, 2022 in Richmond, TX. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Veterinary.

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
August 30, 2022
Fiscal Year
2022
Product Type
Veterinary
Project Area
Monitoring of Marketed Animal Drugs, Feed, and Devices
Location
Richmond, TX (United States)

Additional Details

FSVP

Citations

IDCFRDescription
2243921 CFR 1.506(a)(1)Approved supplier procedures - importer established
2244221 CFR 1.506(b)Supplier verification - establish written procedures
2244421 CFR 1.506(d)(1)(i)Verification activity assurance
2249721 CFR 1.510(b)(1)Record - available