FDA Inspection
Calmare Therapeutics, Inc.Calmare Therapeutics, Inc. – FDA Inspection, Aug 17, 2011
Record Details
This FDA Inspection record concerns Calmare Therapeutics, Inc., with an inspection on August 17, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Calmare Therapeutics, Inc.
- Inspection Date
- August 17, 2011
- Product Type
- Devices
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ID · 6744b873-d3ac-4615-8216-b7f1cb0902ea
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 741709
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
5- 21 CFR 820.20(d)Quality plan
- 21 CFR 820.100(a)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 Calmare Therapeutics, Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| May 22, 2024 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| June 29, 2017 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
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