483
Gland Pharma LimitedFDA 483 - Gland Pharma Limited - July 14, 2023
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Record Details
An FDA inspection of Gland Pharma Limited in Hyderabad, India, from July 3-14, 2023, revealed significant deficiencies in laboratory record-keeping. The firm failed to maintain complete data for various product tests, including injections, sub-visible particles, and sterility testing. These issues indicate a lack of adherence to established specifications and standards for laboratory controls.
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ID · a8b23a0b-1439-46db-b7a7-ac096d7940c7