FDA 483 - Gland Pharma Limited - July 14, 2023

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.