FDA Warning Letter Calls Out Device Distributor

When a device is officially a medical device? And when a distributor is officially a manufacturer? Last warning letter (FDA) of the US Food and Drug Administration for MedSource based in Rhode Island may raise some new issues of companies that do not realize that they must comply with FDA regulations.

For MedSource, the FDA has determined that the distribution of orthopedic surgical instruments trays means that a device manufacturer and distributor because the products "are intended to be used in the diagnosis of disease or other conditions or" in cure, mitigation, treatment or prevention of disease or to affect the structure or any function of the body.

On its website, MedSource describes himself as only a distributor of orthopedic products from other manufacturers, equipment for sports medicine and physical therapy products.

Findings

MedSource Inspection Agency device operations in March found that the company failed to adequately control its warehouses and dormitories share purchase in order to avoid "confusion, damage, deterioration, contamination or other adverse effects to await his use or distribution. "

Inspectors also found that orthopedic trays awaiting delivery to customers have been stored immediately adjacent to an area where employees already inspected trays used in surgery. In addition, the FDA has found an immediate container of fuel near other orthopedic trays and trays of instruments.

The failure to establish acceptance activities MedSource, even returned to the factory for distribution units, was also cited by the FDA, as has been its inability to establish and maintain procedures for verification and validation of corrective and preventive actions.

Other issues on quality systems the company have been raised.

The agency also said MedSource he must be aware that one of the products it distributes - Optecure CCC + (allograft demineralized bone matrix + CCC) - is a medical device because when demineralized bone matrix combined with bone filler material, monitoring the product is considered a medical device, which means "the methods used or the facilities or controls used in the production, packaging, storage or installation must be in accordance with good manufacturing practices (cGMP) requirements for current devices."