FDA 483 - Hetero Labs Limited - Unit III - July 31, 2015

An FDA inspection of Hetero Labs, Ltd. - Unit III in Hyderabad, India, from July 27-31, 2015, revealed significant deficiencies in laboratory controls. Specifically, the firm failed to conduct required hypothesis testing during out-of-specification investigations and did not adequately record incubation times for microbial analysis. These issues indicate a lack of scientifically sound and appropriate test procedures to ensure drug product quality.