# FDA 483 - Sicor de Mexico S.A. de C.V. - December 05, 2023

Source: https://www.globalkeysolutions.net/records/483/sicor-de-mexico-sa-de-cv/b945d8ce-8faf-4481-8a3a-d71db023a908

> FDA 483 for Sicor de Mexico S.A. de C.V. on December 05, 2023. 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: 2023-12-05
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Sicor de Mexico S.A de C.V., an API manufacturer in Lerma, Mexico, was cited for significant deficiencies across its quality control and manufacturing processes. The inspection revealed failures in thoroughly investigating out-of-specification results, ineffective procedures for preventing objectionable microorganisms in drug substances, and inadequate documentation for sampling activities. Additionally, the firm lacked proper monitoring for endotoxins in non-sterile APIs, had insufficient acceptance criteria for API testing, and failed to validate cleaning procedures for non-dedicated equipment.

## Related Documents

- [483 - 2019-12-13](https://www.globalkeysolutions.net/records/483/sicor-de-mexico-sa-de-cv/b41900f3-88ad-4771-a91b-496ab5144410)

## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/alan-m-barker/cf7b4907-0505-418e-860c-815acd534afe)
- [Consumer Safety Officer - Dedicated Foreign Drug Cadre](https://www.globalkeysolutions.net/people/tamil-arasu/94efc491-7d9f-4221-a1ee-69a925acb1c3)
- [Jose M. Cayuela](https://www.globalkeysolutions.net/people/jose-m-cayuela/3ee89bb5-4bba-493b-816f-31b8a9768025)

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

Office: https://www.globalkeysolutions.net/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1