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# Biocon Malaysia Plant Hit with 8-item 483
- URL: https://www.fdaweb.com/biocon-malaysia-plant-hit-with-8-item-483/
- Published: 2023-08-14T12:00:00.000Z
- Updated: 2026-09-14T18:50:10.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5155095

FDA has issued Biocon an eight-item Form FDA-483 after a 7/12-20 inspection of the firm’s Johor, Malaysia manufacturing facility cited significant GMP deficiencies. For example, the inspection observations said the firm’s procedures designed to prevent microbiological contamination are not established, written, or followed.

The [FDA-483](https://www.fda.gov/media/171134/download?attachment&ref=fdaweb.com) also said that the Biocon facility failed to thoroughly review the failure of a batch or any of its components to meet any of its specifications. Additionally, agency investigators said the firm failed to thoroughly review any unexplained discrepancy, specifically that assigned root causes for laboratory out-of-specification results are not always scientifically justified.