# FDA 483 - Medalliance, LLC - June 18, 2026

Source: https://www.keypedia.com/records/483/medalliance-llc/3fa1184b-4d58-4e92-893b-a06df8da6cb3

> FDA 483 for Medalliance, LLC on June 18, 2026. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Medalliance, LLC
- Inspection Date: 2026-06-18
- Product Type: drugs
- Office Name: Los Angeles District Office
- Summary: MedAlliance, LLC, a manufacturer of sterile medical devices and drug formulations in Irvine, CA, was cited for significant deficiencies during an FDA inspection. Observations included inadequate documentation and maintenance of cleanliness and contamination control during sterile device assembly and packaging, specifically concerning a laminar flow hood. Additionally, the firm failed to implement proper production controls for product release, delivery, and post-delivery activities, including a lack of review and verification of production records by the QC unit.

## Related Officers

- [Consumer Safety Officer (Inspector)](https://www.keypedia.com/people/christopher-r-czajka/42defbf3-ea06-4090-8d51-7da2b07d9e84)
- [Luis P. Torres](https://www.keypedia.com/people/luis-p-torres/995f71e1-b7b8-4c30-9d53-2127b01f8d47)
- [Jay-Ar C. Bendo](https://www.keypedia.com/people/jay-ar-c-bendo/c920c6b7-756b-42c7-be52-8b677d192f77)
- [Investigator](https://www.keypedia.com/people/alexandria-l-capuano/f76c710a-613f-42b2-8958-1292fa329112)

Company: https://www.keypedia.com/companies/medalliance-llc/4fed3b78-f87c-4b2b-942a-c582537c51a0

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