# FDA 483 - Sicor de Mexico S.A. de C.V. - December 13, 2019

Source: https://www.globalkeysolutions.net/records/483/sicor-de-mexico-sa-de-cv/b41900f3-88ad-4771-a91b-496ab5144410

> FDA 483 for Sicor de Mexico S.A. de C.V. on December 13, 2019. 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: 2019-12-13
- 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 data integrity issues in its Quality Control Unit, including failure to investigate out-of-specification (OOS) results and inadequate controls over computerized laboratory systems. Additionally, the firm failed to conduct stability studies in a timely manner and lacked adequate cleaning validation for non-dedicated equipment. These observations indicate a systemic breakdown in quality control and manufacturing practices.

## Related Documents

- [483 - 2023-12-05](https://www.globalkeysolutions.net/records/483/sicor-de-mexico-sa-de-cv/b945d8ce-8faf-4481-8a3a-d71db023a908)

## Related Officers

- [Consumer Safety Officer - Dedicated Foreign Drug Cadre](https://www.globalkeysolutions.net/people/tamil-arasu/94efc491-7d9f-4221-a1ee-69a925acb1c3)

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