FDA WARNING_LETTER - Cornerstone Therapeutics Inc.

This FDA Warning Letter (10-ATL-03) was issued to Mr. Collard, following an inspection of a contract manufacturer, (b)(4), in (b)(4). The letter states that Mr. Collard's firm contracted with (b)(4) to manufacture drug products, including (b)(4) and (b)(4), which Mr. Collard's firm distributes.

The FDA determined these products are "new drugs" under section 201(p) of the Act [21 U.S.C. § 321(p)] because they are not generally recognized as safe and effective. They lack FDA-approved applications, violating sections 301(d) and 505(a) of the Act [21 U.S.C. §§ 331(d) and 355(a)].

Furthermore, these prescription drug products are misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)] because they lack adequate directions for use by a layman, as required by 21 C.F.R. § 201.5, and are not exempt under 21 C.F.R. § 201.115. The introduction of these products into interstate commerce without approved applications violates sections