# FDA 483 - Lima USA Inc - July 20, 2021

Source: https://www.keypedia.com/records/483/lima-usa-inc/0d04ebc3-8127-4aa5-a5a4-89ae25e51311

> FDA 483 for Lima USA Inc on July 20, 2021. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Lima USA Inc
- Inspection Date: 2021-07-20
- Product Type: device
- Office Name: New Orleans District Office
- Summary: An FDA inspection of Techmah Medical, LLC in Knoxville, TN, a medical device manufacturer, revealed several significant deficiencies in their quality system. Observations included inadequate supplier agreements, issues with design verification and validation, insufficient supplier records, and a lack of implemented adverse event reporting procedures. These findings indicate a need for substantial improvements in the firm's quality management system.

## Related Officers

- [Gamal A. Norton](https://www.keypedia.com/people/gamal-a-norton/6b52c9e6-d579-4994-81ee-e734eb1f0a67)
- [Benjamin E. Bowen](https://www.keypedia.com/people/benjamin-e-bowen/7fdc5755-0d5d-45c9-93a0-3cb928156c1d)

Company: https://www.keypedia.com/companies/lima-usa-inc/e4ae1884-0e9c-46ac-b5d4-81bebd79340f

Office: https://www.keypedia.com/offices/new-orleans-district-office/95352142-b992-4e06-849d-d7483c0959ea