Zyber Pharmaceuticals, Inc – FDA Warning Letter, Dec 31, 2009

FDA issued a Warning Letter to Zyber Pharmaceuticals, Inc. following an inspection of its contract manufacturer, (b)(4), in (b)(4) 2009. The letter addresses Zyber's distribution of several drug products, including (b)(4) chewable tablets and various (b)(4) oral suspensions, which are deemed "new drugs" lacking FDA-approved applications. This constitutes a violation of Sections 301(d) and 505(a) of the Federal Food, Drug, and Cosmetic Act [21 USC 331(a), (d) and 355(a)]. Furthermore, these prescription products are misbranded under Section 502(f)(1) of the Act [21 USC 352(f)(1)] and 21 CFR 201.5 because their labeling fails to bear adequate directions for use, as they are not amenable to self-diagnosis. The products are also considered adulterated under 21 USC 351(a)(2)(B), prohibiting their introduction into interstate commerce. Zyber Pharmaceuticals is responsible for investigating and correcting these violations promptly. The firm must respond within 15 working days, detailing corrective actions, recurrence prevention steps, and supporting documentation. Failure to comply may lead to legal actions like seizure or injunction, and impact future federal contracts. The violations are not limited to products from the specified manufacturer and apply to all unapproved drugs marketed by Zyber.