FDA EIR - Unknown Company - February 23, 2018

A routine FDA inspection of Parker Hannifin Corporation's Ventura, CA medical device contract manufacturing facility occurred from February 20-23, 2018. The inspection, conducted under C.P. 7382.845 for medical device manufacturers, evaluated the firm's compliance with regulations for producing Class 1, 2, and 3 sterile and non-sterile devices. A Level I QSIT approach was used, focusing on Corrective and Preventive Action (CAPA) and Production & Process Controls subsystems. While no formal FDA Form 483 was issued due to the facility's planned closure and relocation of operations to Merrillville, IN by June 2018, the inspection identified several critical deficiencies. These issues included incomplete complaint records, lacking full investigation details and Medical Device Reporting determinations. Non-conforming Material Reports were also found incomplete, missing justifications for "as is" product use and evaluations of rework or nonconformances. Additionally, Device History Records failed to adequately document the verification of sterilization records. The company also did not take specified actions when cleanroom pressure differential readings were out-of-specification. Finally, calibration records were incomplete, omitting initial out-of-tolerance measurements essential for assessing the impact on tested products. The Business Unit Manager, Mr. Ferguson J. Poliquin, acknowledged these findings and committed to correcting all identified issues, ensuring compliance either at the Ventura facility before its shutdown or at the new Merrillville location.