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# Biocon Malaysian Plant Gets 6-item FDA-483
- URL: https://www.fdaweb.com/biocon-malaysian-plant-gets-6-item-fda-483/
- Published: 2021-10-25T12:00:00.000Z
- Updated: 2026-09-14T17:20:06.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5150432

FDA has posted a six-observation [Form FDA-483](https://www.fda.gov/media/153484/download?ref=fdaweb.com) after inspecting a Biocon drug substance manufacturing facility in Malaysia last month. For example, the heavily redacted form cited the firm for inadequate aseptic behavior and monitoring. It also said its facilities and equipment are not adequately validated and maintained. Additionally, Investigators took issue with the Biocon facility’s cleaning validation and standard operating procedures.