Altaire Pharmaceuticals, Inc. – FDA Warning Letter

The FDA issued Warning Letter NYK-2012-2 to Altaire Pharmaceuticals, Inc., addressing the manufacturing of unapproved new drugs, specifically Freshkote® Sterile Ophthalmic Solution and various Fluorescein Injections. The FDA determined these products are "new drugs" under section 201(p) of the Federal Food, Drug, and Cosmetic Act (the Act) because they lack general recognition of safety and effectiveness for their labeled uses. Consequently, manufacturing and introducing these drugs into interstate commerce without an FDA-approved application violates sections 301(d) and 505(a) of the Act. Furthermore, as prescription drugs under section 503(b)(1), their labeling fails to bear adequate directions for lay use, causing them to be misbranded under section 502(f)(1) of the Act, as per 21 CFR 201.5. The introduction of these misbranded products into interstate commerce constitutes an additional violation of section 301(a) of the Act. Altaire Pharmaceuticals is required to promptly correct these violations. FDA stated its intent to initiate enforcement action if manufacturing continues beyond 90 days or shipment beyond 180 days from the letter date. The firm must respond within 15 working days, detailing plans to cease violative activities, including the cessation date, reasons, and updates to FDA's Drug Registration and Listing System (21 CFR 207.30(a)(2)). Failure to comply may result in legal actions like seizure and injunction, and could affect federal contract awards.