# FDA 483 - Micro Labs Limited - December 08, 2023

Source: https://www.globalkeysolutions.net/records/483/micro-labs-limited/6091e17e-66ba-4088-b19b-e468c581d4e7

> FDA 483 for Micro Labs Limited on December 08, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Micro Labs Limited
- Inspection Date: 2023-12-08
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Micro Labs Limited in Bangalore, India, was inspected by the FDA from December 4-8, 2023, revealing significant manufacturing deficiencies. The firm failed to use dedicated production areas and equipment, leading to potential cross-contamination risks for both U.S. and foreign market products. Additionally, the inspection cited inadequate laboratory testing to ensure product conformance and a failure to demonstrate the suitability of water used in manufacturing, specifically regarding Burkholderia Cepacia contamination.

## Related Documents

- [483 - 2025-08-22](https://www.globalkeysolutions.net/records/483/micro-labs-limited/4792f382-de79-4fd9-aec0-d45e2fd82919)

## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/clinton-j-lott/ac4c7d18-13fd-4b1b-b2a1-06794c9960c7)

Company: https://www.globalkeysolutions.net/companies/micro-labs-limited/e7ff42aa-8d6a-43ec-8bb1-47ff53552057

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