# FDA 483 - Hi Tech Electronic Manufacturing Corporation - February 06, 2025

Source: https://www.globalkeysolutions.net/records/483/hi-tech-electronic-manufacturing-corporation/68054a78-8631-4c76-9ae5-a1597f56e38d

> FDA 483 for Hi Tech Electronic Manufacturing Corporation on February 06, 2025. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Hi Tech Electronic Manufacturing Corporation
- Inspection Date: 2025-02-06
- Product Type: device
- Office Name: Los Angeles District Office
- Summary: An FDA inspection of Hi Tech Electronic Manufacturing Corporation in Oceanside, CA, a medical device manufacturer, revealed significant deficiencies in their quality system. Observations included a lack of established procedures for design transfer and device history records, as well as inadequate documentation and approval of process validation activities for Class II medical devices. These issues indicate a need for improved quality system controls.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/sarah-a-hassas/4f142d54-fc28-4bd5-82ad-7e6fa443688c)

Company: https://www.globalkeysolutions.net/companies/hi-tech-electronic-manufacturing-corporation/6f90cfeb-9e73-497c-9a70-9219b8d3a5ac

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