# FDA 483 - UQUIFA Mexico, S.A. de C.V. - July 23, 2018

Source: https://www.keypedia.com/records/483/uquifa-mexico-sa-de-cv/6590baa9-efdb-4584-bd03-0eeca55aa6fa

> FDA 483 for UQUIFA Mexico, S.A. de C.V. on July 23, 2018. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: UQUIFA Mexico, S.A. de C.V.
- Inspection Date: 2018-07-23
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Uquifa Mexico S.A. de C.V. in Jiutepec, Morelos, Mexico, revealed significant deficiencies in their manufacturing practices. The firm was cited for inadequate laboratory controls, specifically regarding the investigation and resolution of out-of-specification results, and for insufficient control over water used in API operations. Additional observations included incomplete procedures for material handling and a lack of fully established process parameters in cleaning validation, indicating a need for improved quality systems.

## Related Officers

- [Investigator](https://www.keypedia.com/people/michael-a-charles/f83241f0-ae3b-4535-ac03-e790bbf666ca)

Company: https://www.keypedia.com/companies/uquifa-mexico-sa-de-cv/8523a240-e52a-495e-a781-e12c6412dc69

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