FDA 483 - Pausch LLC - March 23, 2026

Pausch LLC, a medical device manufacturer in Tinton Falls, NJ, was inspected by the FDA and received a Form 483 with five observations. The inspection revealed significant deficiencies in the firm's quality management system, including a lack of documented risk analysis, inadequate corrective actions, and insufficient supplier and management review processes. These issues indicate a systemic failure to adhere to established quality procedures for medical device manufacturing.