The federal watchdog said it was responding to a letter it received from Director Dr. Mark Smith at Kelyniam in June.
The FDA this week released warning letters it sent to 2 medical device manufacturers in response to letters related to previous inspections at craniofacial implant maker Kelyniam Global and dialysate maker Diasol.
The federal watchdog said it was responding to a letter it received from Director Dr. Mark Smith at Kelyniam in June after having inspected the company’s Canton, Conn.-based facilities in May, and outlined a total of 7 violations in its response to the company.
The 1st violation the FDA mentioned was a failure to establish and maintain design change procedures, mentioning a new temporal suture system feature to the company’s cranial implants and an integrated fixation system added as an option on its implants and other changes that were not appropriately recorded.
