FDA WARNING_LETTER - Jaymac Pharmaceuticals LLC

This FDA Warning Letter, NO. 2010-NOL-10, was issued to JAYMAC Pharmaceuticals, LLC, specifically to President Harold Robinson. It references a prior warning letter issued to a contract manufacturer, (b)(4), and states that JAYMAC Pharmaceuticals, LLC contracted with (b)(4) to manufacture and distribute drug products.

The identified violations pertain to J-Tan D Suspension and J-Tan D Chewable Tabs. These products are classified as "new drugs" under Section 201(p) of the Act [21 USC 321(p)] because they are not generally recognized as safe and effective. The letter states there are no FDA-approved applications (under Section 505(b) or (j) of the Act [21 USC 355(b) or (j)]) on file for these products, making their introduction into interstate commerce a violation of Sections 301(d) and 505(a) of the Act [21 USC 331(a), (d) and 355(a)].

Additionally, the products are deemed misbranded under Section 502(f)(1) of the Act [21 USC 352(f)(1)] because, as prescription drugs for conditions not amenable to self-diagnosis, they lack adequate directions for laymen as required by 21 CFR