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# Hetero Labs India Warehouse Cited After Inspection
- URL: https://www.fdaweb.com/hetero-labs-india-warehouse-cited-after-inspection/
- Published: 2025-10-27T12:00:00.000Z
- Updated: 2026-09-14T15:25:04.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5160110

FDA has posted a [six-item Form FDA-483](https://www.fda.gov/media/189343/download?ref=fdaweb.com) after inspecting Hetero Labs’ Vishakapatnam, India, warehouse last month. The findings from the inspection are:

- Access to the facility storing active pharmaceutical ingredients, intermediates and key starting materials intended for the U.S. market and associated records were not made readily available for inspection.
- The warehouse was not properly registered with FDA.
- There is no quality unit oversight.
- Procedures describing the warehousing of materials had not been established.
- Failure to establish adequate controls to prevent mix-ups during storage and distribution operations.
- Failure to ensure materials are stored in a manner that prevents potential contamination.