# FDA 483 - Optimal Solution Labs LLC - April 17, 2026

Source: https://www.keypedia.com/records/483/optimal-solution-labs-llc/4d7bb2ee-3165-4e8e-9044-006e8859013e

> FDA 483 for Optimal Solution Labs LLC on April 17, 2026. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Optimal Solution Labs LLC
- Inspection Date: 2026-04-17
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: Optimal Solution Labs LLC, a contract manufacturer of OTC drugs and cosmetics in Valencia, CA, was cited for significant deficiencies in its quality control, material testing, and in-process control procedures. The inspection revealed failures to ensure material suitability, validate supplier Certificates of Analysis, verify component identity, and adequately monitor batch uniformity during manufacturing. These issues indicate a lack of robust quality systems for drug product manufacturing.

## Related Documents

- [483 - 2024-11-06](https://www.keypedia.com/records/483/optimal-solution-labs-llc/e5b282cb-6c99-49a5-99d2-f285f3f364e2)

## Related Officers

- [Consumer Safety Officer](https://www.keypedia.com/people/darren-s-brown/389a4d1f-7f34-42cd-bdc8-5bebd41aff56)

Company: https://www.keypedia.com/companies/optimal-solution-labs-llc/01ccca93-aabc-40d8-9529-e64200a1d834

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