FDA Inspection
WELLSKO LLCFDA Inspection 1258749 - WELLSKO LLC - December 20, 2024
Record Details
This FDA Inspection record concerns WELLSKO LLC, with an inspection on December 20, 2024, issued by the Dallas District Office, covering foods & cosmetics.
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ID · 358aa2ab-04f1-442a-9f02-446125d639fd
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1258749
- FDA center
- Foods & Cosmetics
- Project area
- Foodborne Biological Hazards
- Outcome
- Form 483 issued
FDA Citations
8- 21 CFR 1.506(d)(1)(i)Verification activity assurance
- 21 CFR 1.502(a)Develop FSVP
- 21 CFR 1.505(a)(2)Evaluation - performance, risk
- 21 CFR 1.506(b)Supplier verification - establish written procedures
- 21 CFR 1.506(a)(1)Unapproved supplier procedures - importer established
- 21 CFR 1.506(a)(1)Approved supplier procedures - importer established
- 21 CFR 1.504(a)Hazard analysis written
- 21 CFR 1.510(b)(1)Record - available
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