FDA Inspection
Calmare Therapeutics, Inc.Calmare Therapeutics, Inc. – FDA Inspection, Jun 29, 2017
Record Details
This FDA Inspection record concerns Calmare Therapeutics, Inc., with an inspection on June 29, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 7cce8c09-a26f-486f-83e0-f5e7f0bead0b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1016755
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
5- 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 820.20(b)Lack of or inadequate organizational structure
- 21 CFR 803.17Lack of Written MDR Procedures
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Other FDA inspections of Calmare Therapeutics, Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| May 22, 2024 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| August 17, 2011 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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