# FDA 483 - Fresenius Medical Care de Mexico - December 04, 2018

Source: https://www.keypedia.com/records/483/fresenius-medical-care-de-mexico/caaa82dd-556f-43b3-a51a-c40463a3f3b4

> FDA 483 for Fresenius Medical Care de Mexico on December 04, 2018. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Fresenius Medical Care de Mexico
- Inspection Date: 2018-12-04
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Fresenius Medical Care de Mexico, a sterile drug manufacturer in Zapopan, Jalisco, Mexico, was cited with four observations during an FDA inspection. The firm failed to adequately investigate batch failures and numerous product complaints, did not maintain proper records for equipment calibration and qualification, and had deficiencies in visual inspection procedures and retain sample collection. These issues indicate significant concerns regarding quality control and adherence to manufacturing specifications.

## Related Officers

- [Consumer Safety Officer at Commissioned Corps of the U.S. Public Health Service](https://www.keypedia.com/people/latorie-s-jones/086d0897-7d63-4fa8-bdce-f1d17885abd7)

Company: https://www.keypedia.com/companies/fresenius-medical-care-de-mexico/a425662c-8722-4035-b4f4-5cf408ae88ac

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