A Groveland, Fla.-based company has been taken to task by the FDA for a number of problems at its facility, including failure to identify actions to prevent recurrence of nonconforming products.
In a March 17 warning letter that followed an Oct. 13 to 15, 2015 inspection of the firm, the agency informed Miami Fat Supply — which makes Red Head, Red Head 2 and the Jordy Connection System to help with fat collection — that it failed to respond adequately to reports of faulty products. The company does not have premarket approval for the three devices, thereby making them misbranded, the letter adds.
The FDA cites instances in which the reuse of Red Head 2 has resulted in broken/cracked lids. Although the company plans to remove the product from the market until new lid material or mold is available it “will continue to distribute the Red Head 2 devices to existing customers who have not filed a complaint.”
The letter also hits the company for a melted Jordy Cannula plastic connection. The device was not autoclaved properly; however, “no corrective action has been documented for the reported non-conformance.”
A representative informed the FDA that the firm doesn’t maintain certain records, including a CAPA request log.
In addition, the FDA alleges that the firm failed to validate sterilization processing of its Jordy Connections System and its Red Head 2 products. FDA stated that the company had not conducted or documented numerous design control procedures for Red Head 2, including documentation of design changes regarding gluing of canisters.
FDA also alleged that the company failed to adequately evaluate suppliers, contractors, and consultants in regard to the manufacture of lids, funnels, and Jordan adapters.
FDA noted that the company’s October 28, 2015 response to receipt of a Form 483 inspection evaluation “did not provide adequate supporting evidence that the referenced corrections and planned course of action have been implemented.” The company submitted an additional response in February for review by the agency.
The company could not be reached for comment. — Michael Levin-Epstein