FDA 483 - Shilpa Medicare Limited - September 06, 2019

Shilpa Medicare Limited in Polepally, India, a manufacturer of human drug products, was cited for deficiencies in its quality control laboratory. The inspection revealed that the firm did not follow its written stability testing program, leading to sample analyses exceeding allowed timelines. Additionally, insanitary conditions were observed for QC lab instruments and apparatus, contributing to a high rate of out-of-specification results.