FDA 483 - Sidmak Laboratories India Pvt Ltd - May 13, 2023

Sidmak Laboratories India Pvt. Ltd. in Dehradun, India, received a Form FDA 483 citing significant deficiencies during an inspection. Observations included inadequate equipment qualification and calibration practices, particularly concerning performance qualification and the use of improvised tools for calibration. Furthermore, the firm demonstrated a lack of appropriate controls for computer-acquired data, such as missing audit trails, shared user credentials, and insufficient electronic data backup, alongside a failure to properly validate an analytical method for drug products.