FDA 483 - Little Rapids Corporation - August 23, 2024

During an FDA inspection conducted from August 20-23, 2024, Little Rapids Corporation, a medical device manufacturer in Green Bay, WI, received a Form FDA-483 detailing nine significant observations regarding its quality system. Many of these issues were repeat observations from a prior inspection in 2019, indicating persistent non-compliance with federal quality regulations. The primary concerns highlighted include inadequate documentation and implementation of corrective and preventive actions, with specific instances of unverified effectiveness for supplier corrective actions. The company also failed to ensure its quality policy was fully understood and maintained, evidenced by an undocumented Management Representative and the omission of internal audit results from management reviews. Procedures for accepting incoming raw materials and finished goods were insufficient, and the firm sourced product from unapproved suppliers. A critical repeat observation involved the failure to submit a Medical Device Report (MDR) within 30 days for a patient skin reaction to a pediatric gown reported in 2018. Additionally, personnel training, particularly for internal auditors, lacked proper documentation. Procedures for controlling nonconforming product were deficient, as was the process for evaluating complaints to determine the need for MDRs. Finally, internal quality audits had not been performed or documented since the last inspection. Little Rapids Corporation is required to address these deficiencies by implementing comprehensive corrective actions for each observation, as indicated by their commitment to correct.