483
Alkem Laboratories LimitedAlkem Laboratories Limited – FDA 483, Jul 7, 2022
Record Details
An FDA inspection of Alkem Laboratories Limited in Dhar, Madhya Pradesh, identified a critical issue with the firm's stability testing program. The company's accelerated stability studies and basic stability data are not adequately supported by ongoing full shelf-life studies. This deficiency results in unsupported tentative expiration dates for their drug products, including (b)(4) Tablets USP and (b)(4) Gel USP, evidenced by numerous out-of-specification results.
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ID · 986bb138-e379-4947-954f-46257e20f36b
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