# FDA 483 - Eriochem SA - May 08, 2026

Source: https://www.keypedia.com/records/483/eriochem-sa/75e752e6-14a9-45d4-9a71-de3e3c1a6a47

> FDA 483 for Eriochem SA on May 08, 2026. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Eriochem SA
- Inspection Date: 2026-05-08
- Product Type: drugs
- Office Name: Office of Partnerships
- Summary: Eriochem S.A., a sterile drug product manufacturer in Parana, Argentina, was cited for significant deficiencies in its aseptic processing operations. The inspection revealed failures in thoroughly investigating discrepancies, validating aseptic and sterilization processes, and maintaining an adequate environmental monitoring program. These issues indicate a lack of robust contamination control and quality assurance for sterile drug products.

## Related Documents

- [483 - 2019-11-05](https://www.keypedia.com/records/483/eriochem-sa/540d7e9c-a384-4194-a7dc-3093a0b5d6c2)

## Related Officers

- [Quality System Specialist](https://www.keypedia.com/people/jose-e-melendez/75bd6083-14a4-4bd2-a0e5-9946d4dd37e1)

Company: https://www.keypedia.com/companies/eriochem-sa/e2f01909-c1a5-49e0-a736-041a0c65beba

Office: https://www.keypedia.com/offices/office-of-partnerships/83acc701-fc5a-4876-bb34-7499e31541d3