FDA WARNING_LETTER - Boca Pharmacal Inc.

On July 22, 2010, the FDA issued a Warning Letter to Boca Pharmacal, Inc., following an inspection of their contract manufacturer, (b)(4), in September 2009. The letter addresses drug products distributed by Boca Pharmacal, including Pseudo DM GG Syrup and C-Phen DM Drops, which were manufactured by (b)(4). The FDA determined these products are "new drugs" under section 201(p) of the Act that lack required FDA-approved applications, violating sections 301(d) and 505(a) of the Act. Furthermore, because these prescription drug products are intended for conditions not amenable to self-diagnosis, their labeling fails to bear adequate directions for use as described in 21 C.F.R. § 201.5, rendering them misbranded under section 502(f)(1) of the Act. The introduction of these unapproved new drugs into interstate commerce also violates sections 301(a) and (d) of the Act. Boca Pharmacal is responsible for investigating and correcting these violations promptly. Failure to do so may result in legal action, including seizure and injunction, and could impact future federal contracts. The firm must notify the FDA in writing within fifteen working days of the specific corrective steps taken, including an explanation of how recurrence will be prevented and supporting documentation.