FDA WARNING_LETTER - Wraser Pharmaceuticals - December 31, 2009

This FDA Warning Letter (2010-NOL-04) was issued to Heath Wray, President of WraSer Pharmaceuticals, following an FDA inspection of a contract manufacturer, (b)(4), in (b)(4) 2009. A previous warning letter was sent to (b)(4) on (b)(4), 2009.

WraSer Pharmaceuticals contracted with (b)(4) to manufacture and distribute drug products, including (b)(4) suspension, (b)(4) Chewable Tablets, and (b)(4) suspension. These products are deemed "new drugs" under Section 201(p) of the Act 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 USC 331(d), 355(a)].

Furthermore, these prescription drug products are intended for conditions not amenable to self-diagnosis, meaning adequate directions for laypersons cannot be written, causing them to be misbranded under Section 502(f)(1) of the Act [21 USC 352(f)(1)]. They are not exempt from this requirement under 21 CFR 201.115. The introduction of these unapproved new drugs into interstate commerce violates Sections 301(a)