FDA EIR - Nurse Assist, LLC - March 09, 2020

An FDA follow-up inspection of Nurse Assist, LLC, a manufacturer of Class II medical devices, was conducted from March 5-9, 2020, in Haltom City, TX. This inspection aimed to verify corrections made since a prior October 2018 inspection, which resulted in six FDA 483 observations, an Official Action Indicated (OAI) classification, and a warning letter regarding Quality System and regulatory compliance.During the previous inspection, Nurse Assist faced issues including inadequate Corrective and Preventive Action (CAPA) procedures, leading to recurring bioburden contamination, an unvalidated gamma sterilization process for certain kits (since discontinued), deficiencies in preventing product contamination, insufficient control over nonconforming products, inadequate supplier assessment, and unvalidated software systems.For the 2020 follow-up, the FDA found significant improvements. The firm revised its CAPA procedures, ceased unvalidated sterilization processes, and addressed contamination concerns. They also implemented better nonconformance tracking and upgraded their quality management software to be 21 CFR 820 compliant. Critically, this inspection did not result in an FDA 483. However, four items were discussed with management for correction: a complaint not closed within the required 60 days without justification, a misclassification of labeling suppliers, and two minor observations related to water sample procedures and facility cleanliness. Management agreed to address these discussion items promptly.