FDA WARNING_LETTER - James P. Johnston, CO, dba Midwest Ocular Prosthetics

On May 1, 2009, an FDA inspection of James P. Johnston, CO, dba Midwest Ocular Prosthetics in Michigan City, IN, identified that the firm manufactures artificial eyes and scleral shells, which are classified as medical devices under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act).

The primary violation cited is the firm's failure to fulfill annual establishment registration and device listing requirements. Section 510 of the Act, as amended by the FDA Amendments Act of 2007 (FDAAA), mandates electronic submission of this information between October 1st and December 31st annually. FDA records indicate the firm did not complete these requirements for the period of October 1 to December 31, 2008, and as of March 17, 2010, the registration was still incomplete.

Consequently, all of the firm's devices are deemed misbranded under section 502(o) of the Act (21 U.S.C. § 352(o)), because they were processed in an unregistered establishment and not included in a required list.

The FDA requires prompt corrective action to address these violations. Failure to comply may lead to regulatory actions including seizure, injunction, civil money penalties, and may impact the firm's eligibility for federal contracts. The firm must provide a written response within fifteen