# FDA 483 - Degasa S.A. De C.V. - May 27, 2022

Source: https://www.keypedia.com/records/483/degasa-sa-de-cv/634bf82c-0610-40fc-b7f8-34e16086a76c

> FDA 483 for Degasa S.A. De C.V. on May 27, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Degasa S.A. De C.V.
- Inspection Date: 2022-05-27
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Degasa S.A. De C.V. in Jiutepec, Mexico, from May 23-27, 2022, revealed numerous deficiencies in their drug manufacturing operations. The firm was cited for issues including inadequate raw material sampling, incomplete laboratory records, lack of data integrity controls, and an insufficient stability program. Additionally, observations noted problems with facility construction, equipment design, contamination prevention, and an inadequate number of qualified personnel.

## Related Documents

- [WARNING_LETTER - 2017-09-08](https://www.keypedia.com/records/warning_letter/degasa-sa-de-cv/29e05372-15dd-4d7d-a1dc-b7f933caa438)

## Related Officers

- [Investigator ](https://www.keypedia.com/people/nicole-e-knowlton/8e65400f-249f-45fe-96fc-cb00fec6ae39)
- [Investigator](https://www.keypedia.com/people/rafeeq-a-habeeb/ac58c0b7-bd42-4037-8ccb-bf0351b7744f)

Company: https://www.keypedia.com/companies/degasa-sa-de-cv/24de884a-81fb-4639-a390-40f84bb3af9c

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