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

Source: https://www.keypedia.com/records/483/sandoz-private-limited/a59f5a20-88b6-48c0-b434-2a7c1171cbf1

> 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: Baltimore District Office
- Summary: During an inspection conducted by the U.S. Food and Drug Administration (FDA) from June 24 to July 2, 2024, observations were made at Sandoz Private Limited, a drug products manufacturer located in Navi Mumbai, Maharashtra, India. The inspection resulted in the issuance of an FDA Form 483, indicating potential deviations from regulatory expectations. The primary issue identified concerned the company's procedures designed to prevent objectionable microorganisms in non-sterile drug products. Specifically, the FDA noted deficiencies in the air and surface environmental monitoring programs within the pharmaceutical manufacturing areas, dispensing and sampling booths, and classified areas of the Quality Control microbiological laboratory. The methods used for environmental monitoring were found to be inadequate; for instance, the incubation temperature range and conditions for media plates were not sufficiently robust to capture a comprehensive range of bacteria, yeast, and fungal species as a mixture, thereby failing to accurately mimic actual use conditions. This deficiency raises concerns about the reliability of the environmental monitoring program and the assurance that it provides accurate results regarding microbial control. As a result of these observations, Sandoz Private Limited is expected to evaluate the findings and implement appropriate corrective and preventive actions to ensure the integrity and effectiveness of its microbiological control systems for non-sterile drug products. While the FDA 483 is an initial report of observations, it necessitates a thorough response and resolution from the company to address the identified issues and maintain compliance with good manufacturing practices.

## Related Documents

- [WARNING_LETTER - 2014-08-29](https://www.keypedia.com/records/warning_letter/sandoz-private-limited/961f17f8-0070-4828-9dfd-9c168fba224b)
- [483 - 2024-07-02](https://www.keypedia.com/records/483/sandoz-private-limited/13edb16e-88f9-4372-b066-5db63f36840b)

## 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/baltimore-district-office/6be371ff-03e9-4039-999c-ff170f17a9fa