# FDA 483 - Organo Sintesis, S.A. De C.V. - Unknown Date

Source: https://www.keypedia.com/records/483/organo-sintesis-sa-de-cv/ae41dde3-c578-4491-9eda-ec675b85df4f

> FDA 483 for Organo Sintesis, S.A. De C.V. on Unknown Date. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Organo Sintesis, S.A. De C.V.
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Organo Sintesis, S.A. de C.V. in San Nicolas Tlazala, Mexico, revealed multiple significant deficiencies in their Active Pharmaceutical Ingredient (API) manufacturing operations. Key issues included inadequate quality control procedures, compromised data integrity in computerized systems, insufficient environmental controls, and incomplete employee training. These findings indicate a lack of robust quality management systems, posing a risk to the quality and purity of the APIs produced.

## Related Officers

- [Investigator](https://www.keypedia.com/people/muna-algharibeh/0f0dbd13-b36a-408d-8e42-4625f8de905d)
- [Claudia Perez-Kass](https://www.keypedia.com/people/claudia-perez-kass/1e36fc79-1300-4a3b-b90e-ce1d3ec84670)
- [investigator](https://www.keypedia.com/people/amir-alavi/d7179128-eb3f-489e-97cf-e2c5e5539a00)

Company: https://www.keypedia.com/companies/organo-sintesis-sa-de-cv/0d8f4d8d-0fbd-4c4a-8362-439c74e4f37d

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