483
Glenmark Pharmaceuticals LimitedGlenmark Pharmaceuticals Limited – FDA 483, Sep 27, 2019
Record Details
An FDA inspection of Glenmark Pharmaceuticals Limited, a non-sterile drug manufacturer in Colvale Bardez, Goa, India, revealed two significant observations. The firm failed to adequately correct a previous observation regarding cleaning documentation for equipment and utensils. Additionally, production and process control procedures were not followed, leading to unsealed drums of in-process material.
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ID · 1b6b5a08-12ee-4621-95d3-64968e415cc1
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