FDA WARNING_LETTER - Orthotic & Prosthetic Lab, Inc.

On March 17, 2010, the FDA issued a Warning Letter to Orthotic & Prosthetic Lab, Inc. following an inspection on July 1, 2009. The firm, located in Webster Groves, MO, manufactures orthotic and prosthetic products, including cranial molding helmets, which are classified as medical devices.

The primary violation identified was the firm's failure to fulfill annual establishment registration and device listing requirements. Under section 510 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. § 360), as amended by the FDAAA in 2007, device manufacturers must electronically submit this information between October 1st and December 31st each year. FDA records indicated the firm did not complete these requirements for the period of October 1 to December 31, 2008, and as of March 17, 2010, had still not done so.

This failure renders the firm's devices misbranded under section 502(o) of the Act (21 U.S.C. § 352(o)), as they were manufactured in an unregistered establishment and not included in a required list.

The FDA mandated prompt corrective action, warning that failure to comply could result in regulatory actions such as seizure, injunction, and/or civil money penalties. Federal agencies are also advised of such