FDA EIR - Cipla Limited - August 30, 2016

An FDA inspection of Cipla Limited's Verna Industrial Estate facility in Salcette, Goa, India, was conducted from August 22 to August 30, 2016. This inspection primarily focused on Current Good Manufacturing Practices (cGMP) for sterile human pharmaceuticals, operating under the CDER EES Pre-Approval and Post-Approval framework, and included a review of Field Alert Reports. The regulatory guidance referenced included CPGMs for drug manufacturing and sterile drug process inspections.

Key violations and issues identified included inadequate investigations into complaints of leaking or empty sterile product containers, product failures to meet stability specifications (assay content for sterile solutions and tablets), the presence of difficult-to-clean items in aseptic processing areas, and insufficient periodic integrity testing of sterile product containers. Furthermore, the company failed to file a Field Alert Report for multiple empty container complaints, and issues with incomplete sample data migration into the Laboratory Information Management System (LIMS) were noted. Deficiencies in aseptic processing and a lack of continuous nonviable particle monitoring in certain filling lines were also observed.

As a result, an FDA-483, Inspectional Observations, was issued to Cipla Limited. The inspection was classified as Voluntary Action Indicated (VAI) for cGMP sterile products and Field Alert Reports. Conditional approval for ANDA 209439/001, Bleomycin Sulfate for Injection, was granted, contingent upon the firm adequately addressing these inspectional findings and implementing necessary corrective actions. The firm's contract customers initiated recalls for certain affected product lots.