FDA WARNING_LETTER - Portal Pharmaceutical, Inc.

On November 9, 2009, the FDA issued a Warning Letter to Portal Pharmaceutical, Inc. following an inspection in June 2009 of (b)(4), a contract manufacturer for Portal Pharmaceutical. The letter states that Portal Pharmaceutical, Inc. distributed drug products, including (b)(4) and (b)(4), manufactured by (b)(4), which are considered "new drugs" under section 201(p) of the Act [21 U.S.C. § 321(p)].

These products lack FDA-approved applications, violating sections 301(d) and 505(a) of the Act [21 U.S.C. §§ 331(a), (d) and 355(a)]. Additionally, as prescription drugs intended for conditions not amenable to self-diagnosis, their labeling fails to bear adequate directions for use, causing them to be misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)]. The products are also deemed adulterated under 21 U.S.C. 351(a)(2)(B).

Portal Pharmaceutical, Inc. is responsible for investigating and correcting these violations and preventing recurrence. Failure to promptly correct violations may result in legal action, including seizure and injunction. The firm must