# Umicore Argentina S.A. – FDA 483

Source: https://www.keypedia.com/records/483/umicore-argentina-sa/b59794d5-8519-4cc9-b5a0-b41a9443733d

> FDA 483 for Umicore Argentina S.A. on Unknown Date. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Umicore Argentina S.A.
- Product Type: drugs
- Office Name: Office of Partnerships
- Summary: Unicore Argentina S.A., an API manufacturer in Pilar, Buenos Aires, was cited for significant quality system failures during an FDA inspection. Observations included inadequate investigations for out-of-specification results and complaints, deficiencies in process validation, and poor facility and equipment maintenance. Additionally, the firm demonstrated ineffective control of water systems, pest control, and routinely used materials prior to quality control approval or after expiration.

## Related Officers

- [Research Specialist II](https://www.keypedia.com/people/justin-a-boyd/796c9c9d-02db-486c-bdca-cc259066a0e2)
- [Martin M. Kimani](https://www.keypedia.com/people/martin-m-kimani/fbc296cc-e80e-46f4-a34a-848c8b20da05)

Company: https://www.keypedia.com/companies/umicore-argentina-sa/7653e711-1a10-42b1-88a4-401f40ebfdbb

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