# FDA 483 - KENERIC HEALTHCARE - June 26, 2025

Source: https://www.globalkeysolutions.net/records/483/keneric-healthcare/e539a876-85ff-4d4c-8167-f2dff75413e9

> FDA 483 for KENERIC HEALTHCARE on June 26, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: KENERIC HEALTHCARE
- Inspection Date: 2025-06-26
- Product Type: device
- Office Name: Dallas District Office
- Summary: An FDA inspection of Keneric Healthcare LLC, a medical device manufacturer in Allen, TX, from June 24-26, 2025, identified one significant observation. The firm's internal audit procedure was found to be deficient, as individuals with direct responsibility for audited activities were conducting the audits, compromising independence. This indicates a weakness in the firm's quality system oversight.

## Related Officers

- [Jacey Roy](https://www.globalkeysolutions.net/people/jacey-roy/6c4d5a32-4aa3-43b0-a06f-40757863219e)

Company: https://www.globalkeysolutions.net/companies/keneric-healthcare/18e4cc61-6e9b-4696-a087-73a1ebab0e4d

Office: https://www.globalkeysolutions.net/offices/dallas-district-office/2d1ee9ae-c44c-4494-8186-a920a69b98f9