Hart Enterprises Inc. – FDA EIR, Dec 19, 2014

An FDA inspection of Hart Enterprises Inc., a manufacturer of Class II special application needles, was conducted from December 17-19, 2014, in Sparta, MI. This was a QSIT level 2 inspection performed under the regulatory framework for medical device manufacturers (7382.845). While no FDA Form 483 was issued, two key issues were discussed with management. Firstly, investigators observed missing entries on two of four reviewed Device History Records. Secondly, two instances were noted where a specific production process documentation field was left blank. These findings indicate minor deficiencies in documentation practices. Management committed to addressing these observations by reviewing the issues with relevant personnel and providing training on proper paperwork completion. They also indicated a willingness to revise forms if required to ensure accurate capture of inspection details and information. Prior to this inspection, the company had voluntarily corrected three previous discussion items from a 2012 inspection: implementing written Medical Device Report procedures, enhancing employee training on work instructions, and improving documentation for validation results. Hart Enterprises Inc. remains registered with the FDA for 2014.