FDA WARNING_LETTER - Crescendo Therapeutics LLC - April 28, 2011

On November 17, 2011, the FDA issued a Warning Letter to Crescendo Therapeutics LLC following an inspection from April 20-28, 2011. The inspection identified significant violations of Post-Marketing Adverse Drug Experience (PADE) regulations (21 CFR 310.305) and violations of the Federal Food, Drug, and Cosmetic Act (Sections 505(a) and 502(f)(1)).

The firm was cited for not having written procedures for the surveillance, receipt, evaluation, and reporting of post-marketing adverse drug experiences for HybriSil (methylprednisolone acetate 1% in silicone gel), as required by 21 CFR 310.305(a). Crescendo Therapeutics' May 13, 2011 response to the FDA 483 was deemed insufficient because it stated a procedure was finalized but did not provide a copy for evaluation.

Additionally, Crescendo Therapeutics LLC was found to be distributing HybriSil, an unapproved new drug, in violation of Sections 301(d) and 505(a) of the Act. HybriSil is considered a "new drug" under Section 201(p) and lacks an FDA-approved application. The product is also misbranded under Section 502(f)(1) because it is intended for conditions