# FDA 483 - Micro Labs Limited - June 30, 2026

Source: https://www.keypedia.com/records/483/micro-labs-limited/93a1b61d-ee68-4116-8b84-b1cb4622b2ea

> FDA 483 for Micro Labs Limited on June 30, 2026. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Micro Labs Limited
- Inspection Date: 2026-06-30
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: An FDA inspection of Micro Labs Limited, a sterile drug manufacturer in Bengaluru, Karnataka, revealed significant deficiencies across its quality and production systems. Observations included inadequate investigations into recurring container closure defects, an insufficient environmental monitoring program, and a flawed visual inspection process for sterile drug products. Further issues were noted in maintaining aseptic conditions, cleaning and sanitization practices, and the monitoring of critical utility systems, indicating a broad failure to ensure drug product quality and purity.

## Related Documents

- [WARNING_LETTER - 2014-05-13](https://www.keypedia.com/records/warning_letter/micro-labs-limited/73319eaa-e918-43b0-8918-df7f58e746a6)
- [483 - 2023-05-12](https://www.keypedia.com/records/483/micro-labs-limited/a4a8e77c-fb4a-4614-a8f2-7367397b9ecd)

## Related Officers

- [Rowena S. Nguyen](https://www.keypedia.com/people/rowena-s-nguyen/ae39318e-1653-467c-94cc-26f8929441ac)
- [Angelica M. Hernandez](https://www.keypedia.com/people/angelica-m-hernandez/d66d920c-01b6-4770-a1b5-cac9a1790a0e)

Company: https://www.keypedia.com/companies/micro-labs-limited/62f2df1c-2c1e-4f8b-b4f7-40cf329f9298

Office: https://www.keypedia.com/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8