# FDA 483 - Micro Labs Limited - May 30, 2025

Source: https://www.keypedia.com/records/483/micro-labs-limited/f75a40db-4cfa-4f25-b38f-35f43ebeefac

> FDA 483 for Micro Labs Limited on May 30, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Micro Labs Limited
- Inspection Date: 2025-05-30
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: An FDA inspection of Micro Labs Limited, a drug product manufacturer in Verna, Goa, India, revealed significant deficiencies in their manufacturing process controls and quality system. The firm failed to establish adequate control procedures for monitoring manufacturing processes and did not thoroughly review unexplained discrepancies or out-of-specification results with scientific justification. These findings indicate a lack of robust quality oversight in drug production.

## Related Documents

- [483 - 2024-02-09](https://www.keypedia.com/records/483/micro-labs-limited/b85fe235-26a2-4849-948b-1461f62badc7)

## Related Officers

- [Drug Specialist](https://www.keypedia.com/people/lauren-n-howard/538f77fe-b977-49c9-a5b3-289cf8a6e886)
- [Consumer Safety Officer - Dedicated Foreign Drug Cadre](https://www.keypedia.com/people/tamil-arasu/94efc491-7d9f-4221-a1ee-69a925acb1c3)

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

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