SpineNet, LLC of Winter Park, Florida, was warned by the FDA on May 31, 2013, that the company’s products are adulterated.
The company, founded in 2007, is the developer of the SpineNet ACC (anterior cervical cage) System; an importer/repacker/relabeler of Apollon and Vane Pedicle Screw Systems; and a relabeler/distributor of the SpineNet Bone Marrow Aspiration Needle Kit.
After an inspection that lasted from January 29, 2013 through February 1, 2013, the agency issued a Warning Letter that said the products were adulterated because, “the methods used in, or the facilities or controls used for, its manufacture, packing, storage, or installation are not in conformity with the current good manufacturing practice (CGMP) requirements.”
The company responded to the inspection observations on February 22, 2013, but the agency remains unsatisfied.
The alleged violations include:
- Failure to adequately ensure, when the results of a process cannot be fully verified by subsequent inspection and test, that the process shall be validated with a high degree of assurance and approved according to established procedure. The agency said the firm failed to provide a copy of its validation procedures; failed to indicate why these sterilization cycles were not validated; and failed to provide evidence that the firm has implemented a corrective action to ensure that this does not recur.
- Failure to establish and maintain adequate procedures to ensure all purchased or otherwise received product and services conform to specified requirements.
- Failure to maintain adequate procedures for acceptance of incoming product. During the inspection the company confirmed that it failed to establish acceptance activities to address incoming inspection of components, instrumentation, finished implants, and returned goods.
- Failure to adequately establish procedures for receiving, reviewing, and evaluating complaints by a formally designated unit. The firm does not have a complaint procedure to ensure timely processing of complaints, investigation of complaint, and Medical Device Reporting (MDR) review of complaints.
- For example, a complaint dated June 15, 2012, references a doctor trying to get an Apollon rod (part of the Apollon Pedicle Screw System) to go thru an offset construct and torqued the rod, breaking it. The firm did not document whether the rod tip broke inside the patient or if the tip was required to be retrieved from inside the patient to facilitate MDR review. Another complaint dated January 18, 2013, referenced a Vane Crosslink that opened on one side of the hook during initial surgery. The firm did not document an MDR review of this complaint and told the FDA the complaint investigation was closed.
- Failure to establish adequate procedures for quality audits.
- Failure to adequately establish and maintain procedures for implementing corrective and preventive action (CAPA).
- Failure to establish and maintain adequate procedures to ensure that mix-ups, damage, deterioration, contamination, or other adverse effects to product do not occur during handling.
Reporting, Off-Label Promotion and Mislabeling
The inspection also revealed that the firm failed or refused to furnish material or information respecting the devices that is required by or under the Medical Device Reporting Regulation. For example, there were no definitions of what the firm will consider to be a reportable event.
The inspection also revealed that the SpineNet Bone Marrow Aspiration Needle Kit, which contains the Bone Marrow Aspiration Needle, is adulterated because the firm does not have an approved application for premarket approval (PMA) in effect, or an approved application for an investigational device exemption.
A review of the materials determined that the firm is promoting and marketing the kit for uses with new performance claims and specifications and for a use that does not have FDA clearance or approval.
The agency acknowledged that the firm voluntarily recalled the product until it has validated that is has the proper clearance for the needle.
Finally, the inspection revealed that the Vane and Apollon Pedicle Screw System devices are misbranded, in that the devices were not included in a list required by law.
