# FDA 483 - Laboratorios Haymann S.A. - May 16, 2011

Source: https://www.keypedia.com/records/483/laboratorios-haymann-sa/c281d2a4-e4b1-4c7e-8417-6d0534b1a67b

> FDA 483 for Laboratorios Haymann S.A. on May 16, 2011. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Laboratorios Haymann S.A.
- Inspection Date: 2011-05-16
- Product Type: drugs
- Office Name: Division of International Drug Quality
- Summary: An FDA inspection of Laboratorios Haymann S.A. in Montevideo, Uruguay, a manufacturer of drug products and active pharmaceutical ingredients, revealed two significant observations. The firm failed to follow written procedures for equipment cleaning, as evidenced by observed residue on equipment marked as clean. Additionally, multiple batches of Active Pharmaceutical Ingredient (API) were not included in the stability monitoring program.

## Related Officers

- [Ernest F. Bizjak](https://www.keypedia.com/people/ernest-f-bizjak/55ca2ca9-d548-492a-863d-3658a6197931)

Company: https://www.keypedia.com/companies/laboratorios-haymann-sa/c3126a6f-56b8-4fe7-afa9-d1df29629537

Office: https://www.keypedia.com/offices/division-of-international-drug-quality/f787ba47-67be-40ca-b4c5-4b664b9c1591