# FDA 483 - Grupo Quimico SRL - November 22, 2023

Source: https://www.keypedia.com/records/483/grupo-quimico-srl/4230c2c3-d5f3-4cbc-854b-f65e71a7771b

> FDA 483 for Grupo Quimico SRL on November 22, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Grupo Quimico SRL
- Inspection Date: 2023-11-22
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Grupo Quimico SRL, a contract testing laboratory in Montevideo, Uruguay, was inspected by the FDA and received a Form 483. The inspection revealed significant deficiencies in data integrity, method validation, laboratory controls, and record-keeping practices. These issues indicate a lack of adequate controls to ensure the accuracy and reliability of analytical data for US OTC drug products and raw materials.

## Related Documents

- [WARNING_LETTER - 2023-11-22](https://www.keypedia.com/records/warning_letter/grupo-quimico-srl/caf7d721-08b4-42d9-8c37-37115927945f)

## Related Officers

- [Teresa I. Navas](https://www.keypedia.com/people/teresa-i-navas/43f747c0-18c2-4630-bab9-936204aa93aa)

Company: https://www.keypedia.com/companies/grupo-quimico-srl/6f319fdb-e623-4cfe-9302-9e32352e61e5

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