FDA WARNING_LETTER - Vertical Pharmaceuticals, Inc.

This FDA Warning Letter, dated (b)(4), was issued to Vertical Pharmaceuticals, Inc. concerning drug products, specifically (b)(4), manufactured by (b)(4) under contract. The FDA had previously warned (b)(4) about unapproved new drugs. The product (b)(4) is identified as a "new drug" under section 201(p) of the Act, lacking FDA-approved applications required by sections 301(d) and 505(a). Its introduction into interstate commerce without approval violates sections 301(a) and (d) of the Act. Additionally, the product's labeling fails to bear adequate directions for use, causing it to be misbranded under section 502(f)(1) of the Act, as it is not exempt per 21 C.F.R. § 201.115. The drug product is also deemed adulterated under 21 U.S.C. 351(a)(2)(B). Vertical Pharmaceuticals is responsible for investigating and correcting these violations, which may apply to all unapproved drug products they market. The firm must notify FDA within fifteen working days of specific corrective actions, recurrence prevention steps, and supporting documentation. Failure to comply may result in legal action, including seizure and injunction, and could impact future federal contracts.