FDA Inspection
USA Facemask LLCUSA Facemask LLC – FDA Inspection, Mar 17, 2023
Record Details
This FDA Inspection record concerns USA Facemask LLC, with an inspection on March 17, 2023, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 9e236cb5-ba6a-44bb-b66a-d6a3cbb36319
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1200062
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 820.50(a)(1)Evaluation and Selection, Suppliers, Contractors, etc.
- 21 CFR 820.50(b)Supplier notification of changes
- 21 CFR 820.75(a)Documentation
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