FDA Inspection
Sports Art America, Inc.Sports Art America, Inc. – FDA Inspection, Feb 10, 2022
Record Details
This FDA Inspection record concerns Sports Art America, Inc., with an inspection on February 10, 2022, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Sports Art America, Inc.
- Inspection Date
- February 10, 2022
- Product Type
- Devices
View Company Profile
ID · f29837c5-a42d-49b4-9414-fcb97cb35eac
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1162501
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
6- 21 CFR 820.40Lack of procedures, or not maintained
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.200(a)Servicing - Lack of or inadequate procedures
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Other FDA inspections of Sports Art America, Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| July 9, 2018 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
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