# FDA 483 - Myron L Company - September 19, 2025

Source: https://www.globalkeysolutions.net/records/483/myron-l-company/3657774a-44d3-4ace-bf3a-585942965a65

> FDA 483 for Myron L Company on September 19, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Myron L Company
- Inspection Date: 2025-09-19
- Product Type: device
- Office Name: Los Angeles District Office
- Summary: Myron L Company, a medical device manufacturer in Carlsbad, CA, was cited for significant deficiencies in its complaint handling system. The firm failed to establish and maintain adequate procedures for receiving, reviewing, and evaluating complaints, instead processing device malfunctions through a "Repair Service Order" system that bypassed regulatory requirements. This indicates a serious lack of control over product quality and potential risks related to uninvestigated device failures and unreported events.

## Related Officers

- [Jenny L. Chisem](https://www.globalkeysolutions.net/people/jenny-l-chisem/d9c3fada-4f08-4f1a-9c6c-06a3c521534c)

Company: https://www.globalkeysolutions.net/companies/myron-l-company/5ebef52d-5c22-42e2-a337-a79e56fc5b89

Office: https://www.globalkeysolutions.net/offices/los-angeles-district-office/edcf1dfe-596a-43b8-8df4-07d9cd94763b