# FDA 483 - Cyan Labs S.A. de C.V. - May 16, 2025

Source: https://www.keypedia.com/records/483/cyan-labs-sa-de-cv/f74ae07a-29c7-4ede-9d78-2ff21d85c2ad

> FDA 483 for Cyan Labs S.A. de C.V. on May 16, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Cyan Labs S.A. de C.V.
- Inspection Date: 2025-05-16
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: An FDA inspection of Cyan Labs, S.A. de C.V. in Ciudad Apodaca, Mexico, a manufacturer of OTC drug products, revealed significant deficiencies across its quality system. Observations included inadequate investigations, poor equipment and facility maintenance, insufficient component testing, lack of supplier qualification, unvalidated production processes, and inadequate computer system controls. These issues indicate a broad failure to ensure the quality, purity, and strength of their drug products.

## Related Officers

- [M.S., Consumer Safety Officer at FDA](https://www.keypedia.com/people/daniel-l-zheng/5e3d993f-654e-4d40-a2c8-69c5e396499f)

Company: https://www.keypedia.com/companies/cyan-labs-sa-de-cv/abcf2eec-7036-4182-b7b2-298a3df9dfe5

Office: https://www.keypedia.com/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8