The FDA issued a May 30 warning letter to Restorative Health Services of Nashville, Tenn., for current good manufacturing practices (cGMP) violations related to the firm's cranial orthosis device -- a "helmet" designed to prevent the continued development of an abnormally-shaped head. The firm also failed to follow medical device reporting regulations, the FDA said.
But Restorative Health's CEO has serious questions about the justification for that letter and the FDA's inspection process of his company's facility.
An FDA investigator inspected the company's facility Jan. 23, 30 and 31 and issued the company a Form 483 branding the firm's cranial orthosis product "adulterated."
Specifically, the company's April 3 response letter to the agency "does not contain a [ corrective and preventive action] CAPA procedure," the warning letter says. Furthermore, "your firm does not have any acceptance activity procedures for the components received from your suppliers," the agency says.
In addition, the QS procedure submitted in the firm's April 3 response "does not include procedures for identification, documentation, validation, or, where appropriate, verification, review, and approval of design changes before their implementation," the warning letter states.
The firm's cranial orthosis is "misbranded" because Restorative Health "failed or refused to furnish material or information" and "does not have an internal formal system for evaluating adverse events and submitting" the required medical device reports (MDRs) to the FDA, the letter states.
"Here is why we are 'not compliant,'" Aaron Sorensen, Restorative Health's president and CEO, told FDAnews. "When we had our first site visit several years ago, the site inspector told us -- which we also have in writing from the FDA -- that we were exempt from the QS side of the regulation, but we were not exempt from the labeling side." The company was found to be compliant at that time, Sorensen said.
Devices & Diagnostics Letter