FDA 483 - Repro-Med Systems, Inc. - December 16, 2016

An FDA inspection conducted from November 29 to December 16, 2016, at Repro-Med Systems, Inc., a medical device manufacturer in Chester, NY, revealed significant deviations from regulatory requirements. The Form FDA-483 identified eight key observations, primarily related to the company's quality management system, particularly concerning its compliance with Good Manufacturing Practices for medical devices. One critical issue was the firm's failure to report a correction and removal (effectively a recall) of potentially compromised sterile needle sets and tubing, which posed a risk of infection, to the FDA. This directly impacts patient safety. The inspection also highlighted inadequate procedures for design changes, with the company failing to verify or validate modifications to ensure product integrity. Further observations included systemic weaknesses in the Corrective and Preventive Action (CAPA) system, such as insufficient verification of corrective actions, incomplete investigations into root causes, and a lack of adherence to internal CAPA procedures. The firm also inadequately controlled nonconforming products, often releasing them without proper evaluation, segregation, or documented justification. Complaint handling procedures were found deficient, with complaints not consistently evaluated for reportability or thoroughly investigated. Additionally, critical rework activities were undocumented, design verification testing lacked sufficient rationale, and records for an important supplier were absent, including its qualification status. Repro-Med Systems, Inc. is required to thoroughly investigate these observations, implement comprehensive corrective actions, and submit a detailed response to the FDA outlining how it will address each deficiency and prevent recurrence.