# FDA 483 - McKenna Labs Inc - February 13, 2025

Source: https://www.globalkeysolutions.net/records/483/mckenna-labs-inc/ea984850-2d45-4f02-b6a3-a2eb070cd5d8

> FDA 483 for McKenna Labs Inc on February 13, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: McKenna Labs Inc
- Inspection Date: 2025-02-13
- Product Type: drugs
- Office Name: Los Angeles District Office
- Summary: McKenna Labs Inc, a contract manufacturer in Fullerton, CA, was inspected by the FDA from February 10-13, 2025. The inspection revealed significant deficiencies in batch production and control records, specifically regarding critical process parameters for OTC drug products, and in laboratory records where calculations and raw data for identity testing and yield were incomplete or not properly recorded. These issues indicate a lack of adequate control over manufacturing and testing processes.

## Related Documents

- [483 - 2020-03-05](https://www.globalkeysolutions.net/records/483/mckenna-labs-inc/32371179-3cdc-4a14-b252-8918ed63e497)

## Related Officers

- [Consumer Safety Officer](https://www.globalkeysolutions.net/people/tiara-m-brown/bbc93754-69de-4379-b9f5-f85ea4c8b0e9)

Company: https://www.globalkeysolutions.net/companies/mckenna-labs-inc/a0956f9d-e7ea-4bf6-ac78-77140586f684

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