# FDA 483 - Levlad, LLC - May 19, 2022

Source: https://www.globalkeysolutions.net/records/483/levlad-llc/78ac5e3d-5143-4bf1-a154-7c3bcabd4c6e

> FDA 483 for Levlad, LLC on May 19, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Levlad, LLC
- Inspection Date: 2022-05-19
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: An FDA inspection of Levlad, LLC in Chatsworth, CA, a drug manufacturer, revealed significant deficiencies in quality control and manufacturing practices. The firm failed to adequately investigate product complaints and out-of-specification results, did not properly qualify contract laboratories or conduct annual product reviews, and lacked appropriate testing methods and written production controls for drug products. These issues indicate a systemic breakdown in ensuring product quality and purity.

## Related Officers

- [Dogbeda F. Mackenzie](https://www.globalkeysolutions.net/people/dogbeda-f-mackenzie/c522e2cb-bf53-48f3-b88a-20b7aa0238d6)

Company: https://www.globalkeysolutions.net/companies/levlad-llc/d4c8e261-f129-4c6a-a02d-9c06c4ca8e98

Office: https://www.globalkeysolutions.net/offices/division-of-pharmaceutical-quality-operations-iv/a2d2ff91-dc0f-433e-b91f-ca90ff8998b6