# FDA 483 - Micro Labs Limited - February 09, 2024

Source: https://www.globalkeysolutions.net/records/483/micro-labs-limited/b85fe235-26a2-4849-948b-1461f62badc7

> FDA 483 for Micro Labs Limited on February 09, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Micro Labs Limited
- Inspection Date: 2024-02-09
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Micro Labs Limited received a Form 483 with significant observations related to quality control, equipment cleaning, laboratory controls, and employee training. The firm released drug products with valid Out-of-Specification results, failed to adequately clean manufacturing equipment leading to potential cross-contamination, and delayed reporting Field Alert Reports for over 1.5 years. These issues indicate a systemic breakdown in quality oversight and adherence to cGMP regulations, posing risks to drug product safety and purity in the US market.

## Related Documents

- [483 - 2025-05-30](https://www.globalkeysolutions.net/records/483/micro-labs-limited/f75a40db-4cfa-4f25-b38f-35f43ebeefac)

## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/patty-p-kaewussdangkul/1f0961fc-216e-4580-830a-56a76c0e7cea)
- [Pratik S. Upadhyay](https://www.globalkeysolutions.net/people/pratik-s-upadhyay/22ff2e0b-17d4-4c91-a3f0-c7e30b7a115b)

Company: https://www.globalkeysolutions.net/companies/micro-labs-limited/31ef3982-06b8-43c1-8e7e-585fb2dd02e7

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