Pausch LLC – FDA 483, Nov 9, 2022

Pausch LLC, a medical device manufacturer in Tinton Falls, NJ, was cited with six observations during an FDA inspection. The inspection revealed significant deficiencies across its quality system, including inadequate maintenance of device master and history records, and failures in establishing proper procedures for corrective and preventive actions, complaint handling, nonconforming product control, and employee training. These issues indicate a broad lack of adherence to quality system regulations for medical devices.