FDA Inspection
Wound Healing TechnologiesWound Healing Technologies – FDA Inspection, Mar 2, 2022
Record Details
This FDA Inspection record concerns Wound Healing Technologies, with an inspection on March 2, 2022, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Wound Healing Technologies
- Inspection Date
- March 2, 2022
- Product Type
- Devices
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ID · 8f31b644-dfa7-4af0-b89f-b7e822cb53e7
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1164201
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 820.198(a)Complaints
- 21 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
- 21 CFR 820.200(a)Servicing - Lack of or inadequate procedures
- 21 CFR 803.17Lack of Written MDR Procedures
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