# Sicor de Mexico S.A. de C.V. – FDA 483, Jun 16, 2026

Source: https://www.keypedia.com/records/483/sicor-de-mexico-sa-de-cv/4dd84555-bfc4-46e5-a78c-eea90106a76b

> FDA 483 for Sicor de Mexico S.A. de C.V. on June 16, 2026. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Sicor de Mexico S.A. de C.V.
- Inspection Date: 2026-06-16
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: Sicor de Mexico, S.A. de C.V., an API manufacturer in Mexico, received a Form 483 for significant deficiencies in its quality unit and laboratory controls. The firm distributed APIs to the U.S. market without ensuring they were free from contamination or safety impurities. Additionally, the quality unit failed to conduct thorough investigations into out-of-specification results, compromising product quality assurance.

## Related Documents

- [483 - 2023-12-05](https://www.keypedia.com/records/483/sicor-de-mexico-sa-de-cv/bc00ee48-cc82-4232-945c-8f9bdc407eeb) — date: December 5, 2023
- [483 - 2019-12-13](https://www.keypedia.com/records/483/sicor-de-mexico-sa-de-cv/b41900f3-88ad-4771-a91b-496ab5144410) — date: December 13, 2019

## Related Officers

- [Jose M. Cayuela](https://www.keypedia.com/people/jose-m-cayuela/3ee89bb5-4bba-493b-816f-31b8a9768025)

Company: https://www.keypedia.com/companies/sicor-de-mexico-sa-de-cv/006df4f6-5196-4ece-917c-fad73f51a7e3

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