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# Jubilant Generics Cited Over GMPs
- URL: https://www.fdaweb.com/jubilant-generics-cited-over-gmps/
- Published: 2024-04-05T12:00:00.000Z
- Updated: 2026-09-14T14:27:35.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5156718

FDA has issued Jubilant Generics a four-observation [Form FDA-483](https://www.fda.gov/media/177529/download?attachment&ref=fdaweb.com) after inspecting the firm’s Roorkee, Uttarakhand, India facility in February.

The inspection cited the firm for not making written records for all investigations into unexplained discrepancies. FDA also took issue with the quality control unit and its responsibilities and procedures, which are not in writing and fully followed. For example, the agency says that during the walk-through inspection of your facility, FDA investigators “observed the presence of at least three uncontrolled investigation documents in a locked bin that were placed for shredding.” These documents were prepared outside of the firm’s control and traceability system despite procedures indicating otherwise.

Additionally, the inspection found that time limits are not established when appropriate for the completion of each production phase to assure the quality of the drug product. And, control procedures are not established to validate the performance of the manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product, it said.