# FDA 483 - Micro Labs Limited - May 12, 2023

Source: https://www.keypedia.com/records/483/micro-labs-limited/a4a8e77c-fb4a-4614-a8f2-7367397b9ecd

> FDA 483 for Micro Labs Limited on May 12, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Micro Labs Limited
- Inspection Date: 2023-05-12
- Product Type: drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: An FDA inspection of Micro Labs Limited, a sterile drug manufacturer in Bangalore, India, revealed significant deficiencies across laboratory controls and production systems. The firm failed to adequately investigate out-of-specification results and impurities, with one observation being a repeat finding. Additionally, the inspection identified issues with process validation, in-process controls, and the establishment of adequate written procedures for production and quality assurance.

## Related Documents

- [WARNING_LETTER - 2014-05-13](https://www.keypedia.com/records/warning_letter/micro-labs-limited/73319eaa-e918-43b0-8918-df7f58e746a6)
- [483 - 2026-06-30](https://www.keypedia.com/records/483/micro-labs-limited/93a1b61d-ee68-4116-8b84-b1cb4622b2ea)

## Related Officers

- [Jose F. Velez](https://www.keypedia.com/people/jose-f-velez/0d1951e8-3aa5-48ff-bc54-1fae8a7a57c9)

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

Office: https://www.keypedia.com/offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c