FDA Rescinds Biologics License for Defunct Canadian Firm

After nearly 25 years of trying to reach biologics manufacturer Chembiomed but getting no response, the FDA today revoked the Canadian firm’s license.

According to a notice in the Federal Register, the agency is revoking the biologics license because Chembiomed had not updated any of its product registrations in more than two decades and the FDA was unable to inspect the company’s facilities. A Dec. 19, 2012, letter detailing the agency’s intent to revoke was returned as undeliverable.

According to the notice, a former Chembiomed employee informed the FDA on July 7, 1992, that the company was no longer in business, had stopped manufacturing products and had ceased shipments of products to the U.S.

Health Canada also informed the FDA that the company was no longer in business, the notice says. A government website called Industry Canada shows the agency issued a certificate of dissolution on March 17, 1999.

Read the Federal Register notice at www.fdanews.com/07-07-15-Chembiomed.pdf. — Kellen Owings