FDA Inspection
Sports Art America, Inc.Sports Art America, Inc. – FDA Inspection, Jul 9, 2018
Record Details
This FDA Inspection record concerns Sports Art America, Inc., with an inspection on July 9, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 76515281-e30d-4f5d-a9d4-43e55af7e85d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1058314
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 820.40Procedures not adequately established or maintained
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 803.17Lack of Written MDR Procedures
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Other FDA inspections of Sports Art America, Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| February 10, 2022 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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