FDA EIR - Gland Pharma Limited - August 25, 2022

An FDA inspection of Gland Pharma Limited, located in Medchal-Malkajgiri District, Hyderabad, India, was conducted from August 22 to August 25, 2022. This inspection focused on medical device Current Good Manufacturing Practices (cGMP) under the Quality System Regulation (21 CFR 820), marking the first time the facility was assessed for medical device compliance, distinct from its previous drug cGMP inspections.The inspection revealed several observations on an FDA Form 483, primarily concerning the absence of fully established design control procedures. Specifically, the firm's processes for defining, documenting, and approving design input requirements were deemed insufficient. Additionally, the quality audit checklist was found lacking in its coverage of comprehensive design control elements, including planning, inputs, outputs, verification, validation, and risk analysis. Deficiencies were also noted in the audit's scope for Corrective and Preventive Action (CAPA) activities, such as implementation verification and information sharing. The company's Quality Risk Management procedure also required better definition for risk identification and the consistent application of fundamental assessment questions.Company management, including the Managing Director/CEO, acknowledged these findings, committed to addressing the noted deficiencies, and assured the FDA of a timely written response outlining their corrective measures.