FDA EIR - Busse Hospital Disposables, Inc. - April 13, 2018

An FDA inspection of Busse Hospital Disposables, Inc., a registered Class I and Class II sterile medical device manufacturer located in Hauppauge, NY, took place from April 10 to April 13, 2018. This routine inspection, conducted under Compliance Program 7382.845, focused on the company's compliance with the Quality System Regulation for medical devices (21 CFR Part 820), particularly regarding their Pump Refill Kits. The inspection identified two significant issues, leading to the issuance of an FDA Form 483. Firstly, the company lacked adequately established procedures for monitoring and controlling process parameters for a validated manufacturing process. Specifically, identical content in both the Installation Qualification and Operation Qualification documents for a key towel machine rendered their validation plans indistinguishable and inaccurate. Secondly, Busse Hospital Disposables failed to adequately establish requirements for its suppliers. Despite multiple non-conformances related to syringes from a vendor, the firm did not initiate a required Corrective and Preventive Action (CAPA), contradicting its own established vendor evaluation procedures. Management acknowledged these findings and committed to implementing corrective actions. The FDA Form 483 serves as a formal notification of these deficiencies, requiring the company to address the observations to ensure full compliance with regulatory standards for medical device quality and safety.