# FDA 483 - Meditherm Inc. - September 02, 2022

Source: https://www.globalkeysolutions.net/records/483/meditherm-inc/80f1b391-5980-43b8-b10e-8129ffa15f85

> FDA 483 for Meditherm Inc. on September 02, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Meditherm Inc.
- Inspection Date: 2022-09-02
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: An FDA inspection of Meditherm Inc., a medical device manufacturer in Albuquerque, NM, revealed significant deficiencies in their quality system. The firm failed to establish procedures for design changes, incoming product acceptance, and supplier requirements. Additionally, no quality audits or management review meetings had been conducted in the past three years, indicating a severely lacking quality management system.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/charles-l-larson/4232255d-bfd6-4616-a854-c801e4c23e1c)

Company: https://www.globalkeysolutions.net/companies/meditherm-inc/ae70b280-688b-4d3f-a407-fa2751f5f9a2

Office: https://www.globalkeysolutions.net/offices/division-of-pharmaceutical-quality-operations-iv/a2d2ff91-dc0f-433e-b91f-ca90ff8998b6