Orthotic & Prosthetic Lab Inc. – FDA Warning Letter, Jul 1, 2009

On March 17, 2010, the FDA issued a Warning Letter to Orthotic & Prosthetic Lab, Inc. following an inspection on July 1, 2009, in Webster Groves, MO. The firm manufactures orthotic and prosthetic products, including cranial molding helmets, which are classified as medical devices under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act).

The primary violation identified is the firm's failure to fulfill annual establishment registration and device listing requirements. Under section 510 of the Act, amended by the FDA Amendments Act of 2007 (FDAAA), manufacturers must electronically submit this information between October 1st and December 31st each year. FDA records indicate the firm did not complete these requirements for 2008 and had still not done so as of March 17, 2010.

This non-compliance renders the firm's devices misbranded under section 502(o) of the Act, as they were manufactured in an unregistered establishment and not included in a required list. The FDA requires prompt corrective action to prevent regulatory actions such as seizure, injunction, civil money penalties, and consideration in federal contract awards. The firm must respond in writing within fifteen working days, detailing corrective steps, prevention plans, and documentation, or explain any delay and provide a completion timeline.