FDA 483 - PARAFFIN USA LLC - February 22, 2022

An FDA inspection of PARAFFIN USA LLC, a medical device manufacturer in Phoenix, AZ, revealed three significant quality system deficiencies. The firm failed to maintain proper records for complaint investigations, lacked adequate procedures for sampling methods, and did not document supplier evaluations as required by its own standard operating procedures. These observations indicate a need for improved adherence to quality system regulations.