FDA 483 - Pensar Medical LLC - February 16, 2023

Pensar Medical LLC, a medical device manufacturer in Norco, CA, was issued a Form 483 with six observations following an FDA inspection. The inspection revealed significant deficiencies across its quality management system, including failures in process revalidation, establishing design history files, and adequately documenting corrective and preventive actions. Additional issues involved control of nonconforming products, consultant records, and equipment maintenance documentation, indicating a broad lack of adherence to regulatory requirements.