# FDA 483 - Mission Hills, S.A. de C.V. - May 25, 2018

Source: https://www.globalkeysolutions.net/records/483/mission-hills-sa-de-cv/134223c6-7a67-48e6-b753-9750c8f8d4ce

> FDA 483 for Mission Hills, S.A. de C.V. on May 25, 2018. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Mission Hills, S.A. de C.V.
- Inspection Date: 2018-05-25
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Mission Hills, S.A. de C.V., an OTC drug manufacturer in San Jose Iturbide, Guanajuato, Mexico, was cited for significant deficiencies across multiple systems during an FDA inspection. Observations included inadequate equipment cleaning and maintenance, lack of dual verification for component additions, deficient laboratory controls for water sampling, and severely delayed complaint investigations. Additionally, the firm failed to extend investigations of batch discrepancies to other potentially affected batches.

## Related Officers

- [Pharmacy Compounding National Expert, Drug Specialist, Drug Specialist, Foreign Cadre](https://www.globalkeysolutions.net/people/jessica-l-pressley/2c190e50-81bd-4015-95f0-7177beb363bd)

Company: https://www.globalkeysolutions.net/companies/mission-hills-sa-de-cv/b3b00bab-bd17-4495-92bf-820e72193c5b

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