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# Alkem Labs Hit With 10-item Form-483
- URL: https://www.fdaweb.com/alkem-labs-hit-with-10-item-form-483/
- Published: 2024-04-09T12:00:00.000Z
- Updated: 2026-09-14T14:27:46.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5156742

FDA has issued Alkem Laboratories a 10-observation [Form FDA-483](https://www.fda.gov/media/177580/download?attachment&ref=fdaweb.com) after inspecting the firm’s Baddi, Himachal Pradesh, India manufacturing facility last month. The agency inspection cited Alkem for failing to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications. For example, the facility retired a UV spectrophotometer after it malfunctioned, but it did not perform an investigation or any impact assessment on previously generated test results from the equipment before recording the malfunction.

The inspection also took issue with Alkem’s responsibilities and procedures applicable to the quality control unit. For example, FDA investigators said the firm has not performed “shipping studies” for finished products shipped to U.S. markets as required by the its standard operating procedure. It also found that change controls are not managed and closed within the specified timeframe.

Additionally, FDA’s inspection cited the firm over its separate or defined areas for manufacturing/operations to prevent contamination or mix-ups, which it said were deficient because the movement of personnel and gowning process are not defined. And, FDA said buildings used in the firm’s manufacturing/operations are not maintained in a good state of repair. For example, washing and toilet rooms lacked hot water.