Focus Laboratories, Inc – FDA Warning Letter

On November 16, 2011, the FDA issued a Warning Letter to Focus Laboratories, Inc., specifically addressing their distribution of Freshkote® Sterile Ophthalmic Solution. The FDA determined this product, containing 2% polyvinyl pyrrolidone, 0.9% polyvinyl alcohol, and 1.8% polyvinyl alcohol, is an unapproved new drug.

The product is classified as a "drug" under sections 201(g)(1)(B) and (C) of the Act and a "new drug" under section 201(p) because it is not generally recognized as safe and effective for its labeled uses. Its introduction into interstate commerce without an FDA-approved application violates sections 301(d) and 505(a) of the Act.

Furthermore, as a prescription drug, it lacks adequate directions for lay use, making it misbranded under section 502(f)(1) of the Act, a violation of section 301(a). The FDA stated it would not initiate enforcement action for manufacturing Freshkote® for 90 days, and for distribution for 180 days, unless other violations occur, distribution volume increases, or new health risks emerge.

Focus Laboratories must investigate and correct these violations, ensuring compliance with federal law. A written response is required within 15 working days, detailing plans to cease violative activities, reasons for