Prollenium Medical Technologies Inc. – FDA 483, Nov 9, 2023

During an FDA inspection from November 6-9, 2023, Prollenium Medical Technologies Inc., a medical device manufacturer, received an FDA Form 483 detailing five significant observations related to its quality system requirements. Key issues included inadequate process validation documentation for the sealing machine used for sterile syringes and needles, lacking specific process variables, consideration for material thickness variation, and evidence of consistent sealing throughout production runs. The company's in-process visual inspection procedures for Class III implantable medical devices were also found to be deficient, with concerns regarding inspection scope, imprecise fill volume determination, discrepancies in reported inspection rates, and clarity on measurement methods. Furthermore, the firm's risk analyses for its Revanesse Class III dermal fillers were deemed inadequate, particularly in assessing the severity of potential harms such as infection or anaphylaxis. The inspection also identified failures in supplier management, specifically the use of an unapproved supplier for sterilization and testing of Class III devices, and an ill-defined, subjective supplier re-evaluation process. Prollenium Medical Technologies Inc. acknowledged all observations and committed to implementing corrective actions to address these deficiencies.