FDA WARNING_LETTER - Centrix Pharmaceutical Inc - December 31, 2009

This Warning Letter to Centrix Pharmaceutical, Inc. addresses significant violations identified during an FDA inspection in (b)(4) 2009. The firm contracted with (b)(4) to manufacture and distribute drug products, including (b)(4) Suspension and (b)(4) Suspension. The FDA determined these products are "new drugs" under 21 USC 321(p) that lack required FDA-approved applications. Consequently, their introduction or delivery into interstate commerce violates Sections 301(a) and (d) and 505(a) of the Federal Food, Drug, and Cosmetic Act [21 USC 331(a), (d) and 355(a)]. Furthermore, the products are misbranded under Section 502(f)(1) [21 USC 352(f)(1)] because their labeling fails to bear adequate directions for use, as they are not amenable to self-diagnosis (21 CFR 201.5) and are not exempt (21 CFR 201.115) due to lacking approved applications. The drug products are also deemed adulterated under 21 USC 351(a)(2)(B), prohibiting their interstate commerce (21 USC 331(a)). Centrix is responsible for investigating and correcting these violations promptly. The firm must respond within 15 working days, detailing corrective actions, recurrence prevention, and supporting documentation. Failure to comply may lead to legal action, including seizure and injunction, and could affect federal contracts.