FDA 483 - Phillips Medisize LLC - March 06, 2025

Phillips - Medisize, LLC. in Menomonie, WI, was inspected by the FDA from March 3-6, 2025, and received a Form 483 with four observations. The inspection revealed significant issues including a failure to thoroughly investigate out-of-specification results for product components and deficient complaint investigations that did not extend to other affected batches. Additionally, the firm lacked adequate written procedures for document retention, specifically regarding DSCSA requirements, and failed to implement appropriate controls over computer systems, evidenced by the use of shared and openly displayed login credentials.