ABRYL LABORATORIES PRIVATE LIMITED – FDA EIR, Dec 6, 2022

Abryl Laboratories Private Limited underwent an FDA Pre-approval inspection from November 29 to December 6, 2022, concerning its sterile finished drug manufacturing processes. This inspection, conducted under CP 7346.832 for pre-approval assessments, followed a previous "Official Action Indicated" classification in January 2022, highlighting persistent compliance challenges. The recent inspection resulted in a 5-item Form FDA-483, identifying significant deficiencies. Key violations include: procedures designed to prevent microbiological contamination of sterile drug products were not adequately established, written, or followed, encompassing issues with cart sanitization, glove cleanliness assessment, environmental monitoring locations, and inadequate handwashing facilities in aseptic gowning areas. Furthermore, the company lacked robust written procedures for production and process controls to ensure drug product identity, strength, quality, and purity, particularly concerning visual inspector qualification criteria and defect examples. The inspection also noted insufficient control procedures to validate manufacturing processes, citing incomplete hold-time studies, inadequate assessment of filled volume during continuous operation, and unestablished ranges for vial stopper insertion settings. Aseptic processing areas exhibited deficiencies in cleaning and disinfecting systems, specifically lacking scientific justification for critical sampling methods. Lastly, the firm's system for investigating unexplained discrepancies was found to be inadequate, with an informal impact assessment process subverting formal deviation investigation procedures. Abryl Laboratories management acknowledged the observations and committed to submitting a written response to the agency within 15 business days.