# Micro Labs Limited – FDA 483, Aug 22, 2025

Source: https://www.keypedia.com/records/483/micro-labs-limited/9f6aa0cd-dcaf-4cf7-9003-edca1f263187

> FDA 483 for Micro Labs Limited on August 22, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Micro Labs Limited
- Inspection Date: 2025-08-22
- Product Type: drugs
- Office Name: Office of Partnerships
- Summary: Micro Labs Limited, an Active Pharmaceutical Ingredient Manufacturer in Bangalore, India, was cited for four significant observations during an FDA inspection. The firm demonstrated deficiencies in investigating out-of-specification results and implementing timely corrective actions, managing major facility changes, and ensuring accurate microbiological data through adequate procedures. Additionally, the inspection revealed a lack of control over its computerized water system, including shared access and unreviewed alarm audit trails, indicating a moderate level of non-compliance with good manufacturing practices.

## Related Documents

- [483 - 2023-12-08](https://www.keypedia.com/records/483/micro-labs-limited/6091e17e-66ba-4088-b19b-e468c581d4e7) — date: December 8, 2023

## Related Officers

- [Consumer Safety Officer/ Federal Investigator](https://www.keypedia.com/people/lisa-l-flores/465a6807-55d7-4c3f-a415-c21ac4517bc9)

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

Office: https://www.keypedia.com/offices/office-of-partnerships/83acc701-fc5a-4876-bb34-7499e31541d3