FDA 483 - Patrin Pharma, Inc. - October 18, 2022

Patrin Pharma, Inc., a medical device specification developer in Niles, IL, was cited with three repeat observations during an FDA inspection. The firm failed to establish adequate procedures for design control, corrective and preventive actions, and complaint handling. These deficiencies led to issues such as uncleared pathogen-inhibiting claims on H-Chlor device labeling and inadequate investigation of product complaints.