FDA EIR - Bryllan Llc - January 17, 2025

This FDA Establishment Inspection Report details a routine QSIT Level II baseline inspection of Bryllan LLC, a Class II medical device manufacturer, conducted from January 13-17, 2025. This was the firm's first inspection, covering CAPA, Design Controls, Management Controls, and Production & Process Controls subsystems. The inspection identified five key deficiencies: 1. Risk Management: Incomplete or incorrect risk calculations were found in a process Failure Mode Effects Analysis (pFMEA), potentially understating residual risks. 2. Supplier Management: The firm failed to conduct required periodic monitoring of critical suppliers, with monitoring forms missing for 2022 and 2023. 3. CAPA Effectiveness Checks: A Corrective and Preventive Action (CAPA) lacked documented effectiveness checks despite being closed. 4. Employee Training: A production technician was observed performing an operational task without documented training for the specific procedure. 5. Validation Documentation: Installation and Operational Qualification (IQ/OQ) documentation for newly acquired equipment showed missing or incorrect completion. During the closing meeting, these issues were discussed with management. While no immediate legal sanctions or formal required actions were issued at that time, the FDA informed the firm about contacting them with planned corrections if they chose to do so, noting potential future violations of the FD&C Act. The firm initiated some voluntary corrections during the inspection.