FDA 483 - Gilead Sciences, Inc. - April 26, 2013

Gilead Sciences, Inc. received an FDA Form 483 following an inspection from April 10 to April 26, 2013. The observations highlight significant deficiencies in the company's manufacturing and quality control systems, indicating non-compliance with current Good Manufacturing Practices (cGMP). Key violations included the absence of established or adequately validated test methods for release and stability testing of various drug substances and products. The suitability of some testing methods was not verified under actual use conditions, and an unqualified instrument was utilized for critical analyses. Laboratory records were incomplete, lacking traceability and showing missing data and unexplained discrepancies. Further issues involved inadequate control procedures for manufacturing processes, specifically unvalidated bulk hold studies for drug product intermediates. Test method procedures and their changes were not consistently reviewed and approved by the quality assurance unit. The firm also failed to adhere to its written stability testing program, resulting in delayed testing and lack of deviation evaluations. Additionally, equipment usage logs for balances and pH meters were not properly maintained, and laboratory controls for ensuring component quality were deficient, exemplified by unvalidated instrument cleaning methods and uncontrolled laboratory documentation (worksheets and logbooks, including data integrity concerns like white-outs). Gilead Sciences is required to address these observations comprehensively to ensure the quality, safety, and efficacy of its pharmaceutical products and to bring its operations into full compliance with cGMP regulations.