The FDA published a warning letter it sent to Aros Surgical Instruments requesting the firm cease sales of its surgical sutures and micro anastomosis clamps.
The letter was sent based upon issues the agency found during a February inspection of the company’s Newport Beach, Calif. location.
The federal watchdog reported that the company had responded later in February to its initial concerns, and the FDA produced the warning letter in response. The letter addressed a list of violations the firm found.
The FDA said that changes to the sterilization method and materials of the company’s micro anastomosis clamp “may have affected the biocompatibility of the device,” the letter noted.
“The material change […], the addition of the curved design and changing the closing force of the clamps without any testing could significantly affect the safety and effectiveness of the device. Therefore, a new 510(k) is required for these changes,” the agency wrote in its warning letter.
Due to the significant changes, the FDA requested that the company cease any commercial distribution of the devices.
“Our office requests that AROSurgical Instruments Corporation immediately cease activities that result in the misbranding or adulteration of the above-referenced surgical sutures and micro anastomosis clamps, such as the commercial distribution of the device for the uses discussed above,” the FDA wrote.
The FDA inspector noted a failure to establish and maintain design control procedures, such as a failure to maintain control documentation for the design of its surgical sutures. The Agency said the company had responded to the violation, but found the responseinadequate.
Aros Surgical was hit with a failure to establish and maintain identification, documentation, validation or verification procedures for design changes before implementation. The FDA noted a few marked implemented design changes without identifying and documenting changes in sterilization methods. The Agency also said that it had received a response from the company that was inadequate.
The Agency said the company failed to guarantee its purchased products and services conformed to specified requirements, and had failed to maintain data to that end, including any changes from suppliers and contractors.
Failures to maintain device master records, records of documentation changes and a failure to ensure quality auditors do not have direct responsibility were also referenced by the FDA.
The FDA requested a response from the company within 15 days.