# FDA 483 - Hetero Labs Limited (Warehouse) - September 25, 2025

Source: https://www.keypedia.com/records/483/hetero-labs-limited-warehouse/b63a0cb2-5cf3-40f3-8ed4-f7a2d3f0e034

> FDA 483 for Hetero Labs Limited (Warehouse) on September 25, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Hetero Labs Limited (Warehouse)
- Inspection Date: 2025-09-25
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Hetero Labs Limited (Warehouse) in Vishakapatnam, India, was inspected and cited for severe deficiencies in its operations. The inspection revealed a denial of access to the warehouse, an undisclosed facility status with the FDA, and a complete lack of quality unit oversight and essential cGMP controls. Significant issues included undocumented material receipt, improper labeling, absence of SOPs, inadequate inventory management, and widespread contamination risks from damaged containers and pest infestations.

## Related Officers

- [Constance L. Richard Math](https://www.keypedia.com/people/constance-l-richard-math/9a61f4c9-62ba-4b09-b843-968d9d394b6f)
- [Investigator](https://www.keypedia.com/people/guerlain-ulysse/aeef6f71-43b1-4116-b563-8bb3f2966d6a)

Company: https://www.keypedia.com/companies/hetero-labs-limited-warehouse/dd9c01c1-8a20-46af-9dc7-74122c10ec40

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