The FDA cited Elite Medical Supply of New York for problems with its design control procedures and handling of CAPAs and complaints.
Investigators issued the Form 483 after a December 2017 inspection of the device specification developer’s West Seneca, New York facility. They found the design for the company’s Elite Medical Multi-Mode Stimulator was bought from another company but that Elite Medical did not document a review or approval of the design history file to ensure completeness and accuracy. Moreover, the company had no procedures for introducing outside designs.
Investigators also found that procedures for design validation did not include any requirement to demonstrate equivalency to the production units.
The agency also found that several complaints were reviewed for units identified as “dead on arrival” due to batteries not being charged ahead of shipment. The firm’s quality assurance manager said a corrective action was taken to prevent the problem, but this was not documented in a CAPA.
The company’s complaint-handling procedures also did not require documenting the complainant’s address or phone number, replies to the complainant or dates of the subsequent investigation. At least one of the complaint reports also lacked complainant information.