# FDA 483 - Calmare Therapeutics, Inc. - May 22, 2024

Source: https://www.keypedia.com/records/483/calmare-therapeutics-inc/7735acd8-ba51-4fd1-9c26-432776b32d26

> FDA 483 for Calmare Therapeutics, Inc. on May 22, 2024. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Calmare Therapeutics, Inc.
- Inspection Date: 2024-05-22
- Product Type: device
- Office Name: New England District Office
- Summary: An FDA inspection of Calmare Therapeutics, Inc. in Shelton, CT, a specification developer for a Class II Scrambler Therapy MC-5A TENS device, revealed significant deficiencies in their quality system. The firm was cited for not establishing fundamental procedures for design control, quality audits, management review, MDRs, complaint handling, and corrective and preventive actions. Several of these observations were repeats from a previous inspection in 2017, indicating a persistent lack of compliance with essential regulatory requirements.

## Related Officers

- [Katarzyna Plona](https://www.keypedia.com/people/katarzyna-plona/ea20d6c6-5d2d-41a0-a755-0647fb9f3250)

Company: https://www.keypedia.com/companies/calmare-therapeutics-inc/fc5ecddb-c7f0-43fd-bad2-223954864495

Office: https://www.keypedia.com/offices/new-england-district-office/aa458072-2f1d-4231-89f5-21ba7a3b7144