# FDA 483 - Sandoz Private Limited - July 02, 2024

Source: https://www.keypedia.com/records/483/sandoz-private-limited/13edb16e-88f9-4372-b066-5db63f36840b

> FDA 483 for Sandoz Private Limited on July 02, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Sandoz Private Limited
- Inspection Date: 2024-07-02
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Sandoz Private Limited in Navi Mumbai, India, from June 24 to July 2, 2024, identified a significant deficiency in the firm's procedures for preventing objectionable microorganisms in non-sterile drug products. The environmental monitoring program, particularly the microbiological laboratory's practices for capturing contaminants, was found to be inadequate, compromising the accuracy and reliability of results.

## Related Documents

- [WARNING_LETTER - 2014-08-29](https://www.keypedia.com/records/warning_letter/sandoz-private-limited/961f17f8-0070-4828-9dfd-9c168fba224b)

## Related Officers

- [Jose M. Cayuela](https://www.keypedia.com/people/jose-m-cayuela/3ee89bb5-4bba-493b-816f-31b8a9768025)

Company: https://www.keypedia.com/companies/sandoz-private-limited/951a0c7e-ffd5-45d2-bd94-f8e91f5e39a4

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