# FDA 483 - Laurus Labs Limited - January 31, 2025

Source: https://www.keypedia.com/records/483/laurus-labs-limited/28e9b326-59b0-4d4f-9907-23d17b44a5a6

> FDA 483 for Laurus Labs Limited on January 31, 2025. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Laurus Labs Limited
- Inspection Date: 2025-01-31
- Product Type: Drugs
- Office Name: Office of Inspections and Investigations
- Summary: During an inspection conducted from January 27 to January 31, 2025, the U.S. Food and Drug Administration (FDA) issued a Form 483 observation to Laurus Labs Limited, an API manufacturer located in Anakapalli District, Andhra Pradesh, India. The primary issue identified by investigators Jessica S Estriplet and Olumide A Akinyemi was the firm"s failure to ensure that written procedures, particularly equipment qualification protocols, were appropriately drafted, reviewed, and approved by the quality control unit. Specifically, multiple pieces of equipment used in the manufacturing of active pharmaceutical ingredients (APIs) were observed to have undergone qualification (Installation, Operational, and Performance Qualification) without prior approval of their respective protocols by the quality unit. This observation highlights a deficiency in the company"s adherence to established quality system requirements for manufacturing controls. Laurus Labs Limited is expected to address this observation by implementing corrective actions to ensure all equipment qualification activities are governed by properly approved protocols and that all relevant procedures meet regulatory expectations.

## Related Officers

- [Olumide A. Akinyemi](https://www.keypedia.com/people/olumide-a-akinyemi/a520acd2-450c-4624-a7af-b871e4fad9c7)
- [Drug Investigator](https://www.keypedia.com/people/jessica-s-estriplet/b7152ec3-6e1b-45aa-840e-7147f357aea2)

Company: https://www.keypedia.com/companies/laurus-labs-limited/5b25ff33-3634-4c5a-ad0c-2a1dba0c1efb

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