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.
The FDA said it reviewed the company’s response to the violation and concluded “that it is not adequate,” saying that despite providing a timeline for corrective actions, the company had not provided supporting documentation.
The 2nd violation noted was a failure to evaluate complaints to “determine whether the complaint represents an event which is required to be reported to the FDA,” which the agency said it had received a response to and again concluded that it was inadequate, with similar issues to the 1st violation.
The last 5 violations, including failure to demonstrate that devices were manufactured in accordance with a device master record, a failure to validate processes, a failure to establish procedures for accepting incoming products, a failure of management to review suitability and effectiveness of quality systems and a failure to establish corrective and preventive actions procedures were met with similar complaints about supporting documentation from the FDA.
The federal watchdog instructed the company to take prompt action and notify it within 15 business days, according to the warning notice.
In its letter to Diasol, the FDA said it was responding to an earlier letter it received from the company in July relating to a June inspection of its San Fernando, Calif.-based facilities.
In the response, the federal watchdog noted 15 violations it did not deem the company had appropriately responded to.
The 1st violation mentioned by the FDA was a failure to develop, conduct, control and monitor production processes to ensure device conformity. The agency said it received a response from the company, and that the response was not acceptable, providing a list of corrections the company still had to make.
Additional violations included a failure to establish and maintain a design history file for each of its devices, a failure to establish and maintain procedures for device design verification, a failure to establish and maintain procedures to control device design to ensure they meet design requirements, a failure to complete a device master record, a failure to establish and maintain procedures ensuring finished products meet acceptance criteria and a failure to ensure manufacturing equipment met requirements.
For each violation, the FDA laid out a number of different objections, with the agency again requesting a response within 15 days from the company with threats of seizure, injunction and civil money penalties, according to the warning notice.