# FDA 483 - Minta Medical Limited - July 28, 2022

Source: https://www.keypedia.com/records/483/minta-medical-limited/1dfd25bb-9031-4221-b60f-eeae204cc53f

> FDA 483 for Minta Medical Limited on July 28, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Minta Medical Limited
- Inspection Date: 2022-07-28
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: Minta Medical Limited, a medical device manufacturer in Prescot, United Kingdom, received an FDA Form 483 citing significant quality system deficiencies. Observations included inadequate process validation for their Disposable R-F Thermocouple Electrode, specifically concerning sterility testing and requalification intervals. The firm also lacked established procedures for statistical techniques and failed to maintain a device master record for the product.

## Related Officers

- [Sara M. Onyango](https://www.keypedia.com/people/sara-m-onyango/643c6ad3-9747-4bc2-9e8e-72f97b11e659)

Company: https://www.keypedia.com/companies/minta-medical-limited/4ff7ea99-9e48-4331-8690-07fc5067ee88

Office: https://www.keypedia.com/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd