# FDA 483 - Eksa Mills S.A. de C.V. - April 19, 2022

Source: https://www.globalkeysolutions.net/records/483/eksa-mills-sa-de-cv/7a2052dd-79d0-4dc4-b191-7e3053aa6532

> FDA 483 for Eksa Mills S.A. de C.V. on April 19, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Eksa Mills S.A. de C.V.
- Inspection Date: 2022-04-19
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Eksa Mills S.A. de C.V., an OTC drug manufacturer in Heroica Puebla De Zaragoza, Mexico, was inspected by the FDA. The inspection revealed significant deficiencies, primarily the complete absence of a quality control unit. This led to widespread issues including a lack of written procedures, inadequate record-keeping, no stability program, insufficient component testing, and poor equipment cleaning protocols for drug products shipped to the U.S. market.

## Related Documents

- [WARNING_LETTER - 2022-04-19](https://www.globalkeysolutions.net/records/warning_letter/eksa-mills-sa-de-cv/ecac7e9f-0a20-48e9-b29f-7d85aa424df9)

## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/lisa-shin/13c87687-fe3d-41a5-8973-42be901a5b0c)
- [Joel D. Hustedt](https://www.globalkeysolutions.net/people/joel-d-hustedt/29440042-08dd-4dce-be48-b55f8e1d7080)

Company: https://www.globalkeysolutions.net/companies/eksa-mills-sa-de-cv/ae679e12-a384-4cf8-9a1c-12d13806f8a4

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