FDA WARNING_LETTER - Poly Pharmaceuticals, Inc

The FDA issued a Warning Letter to Poly Pharmaceuticals, Inc. after identifying issues related to drug products manufactured by their contract partner, (b)(4), and distributed by Poly Pharmaceuticals. The products, including Ala-Hist Tablets and Ala-Hist D Tablets, were determined to be "new drugs" under Section 201(p) of the Act, lacking required FDA-approved applications. This constitutes a violation of Sections 301(a) and (d) of the Act for introducing unapproved new drugs into interstate commerce. Additionally, the prescription drug products' labeling fails to bear adequate directions for use, rendering them misbranded under Section 502(f)(1) of the Act [21 USC 352(f)(1)]. The products are also considered adulterated within the meaning of 21 USC 351(a)(2)(B), prohibiting their introduction into interstate commerce. Poly Pharmaceuticals is responsible for promptly correcting these violations. Failure to do so may result in legal actions, including seizure and injunction, and could impact future federal contracts. The firm must respond within 15 working days, detailing specific corrective actions, recurrence prevention measures, and supporting documentation.