The US Food and Drug Administration (FDA) has added Canada's Cosmetic Manufacturers Inc. (CMI) to a list of companies that have been banned from shipping products to the US.

CMI manufactures cosmeceuticals, nutraceuticals and pharmaceuticals, including a digestive enzyme therapy, according to its website. The company says it has a Drug Establishment License and owns the rights to many Drug Identification Number products under the CMI name.

The updated FDA import alert list did not go into detail about the violations that caused CMI to be added to it, though it did cite current good manufacturing practice (cGMP) issues.

Warning Letter

In an FDA warning letter to the company from 2013, agency inspectors at CMI's Concord, Ontario manufacturing site said they identified significant cGMP violations. Among those, the company failed to withhold from use each lot of components, drug product containers, and closures until the lot had been sampled, tested, or examined and released for use by the quality control unit.

CMI also failed to establish and follow written procedures for the preparation of master production and control records, which can assure batch uniformity. The possibility of cross-contamination was another issue FDA cited as a reason for the letter.

In addition, CMI failed to register with the FDA in 2011 and 2012 as a firm that manufactures and imports drugs to the US.

The company could not be reached for comment by press time as the phone number listed on its web site is no longer in service.

Import Alert List