# FDA WARNING_LETTER - Jaymac Pharmaceuticals LLC - Unknown Date

Source: https://www.keypedia.com/records/warning_letter/jaymac-pharmaceuticals-llc/f9752839-08d9-43ba-b7aa-353ac71fbbd4

> FDA WARNING_LETTER for Jaymac Pharmaceuticals LLC on Unknown Date. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Jaymac Pharmaceuticals LLC
- Product Type: Drugs
- Office Name: New Orleans District Office
- Summary: 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

## Related Officers

- [H.](https://www.keypedia.com/people/tyler-thornburg/611c288f-255c-4a1a-9914-14ff1363e7b3)

Company: https://www.keypedia.com/companies/jaymac-pharmaceuticals-llc/6ef28647-d657-40a9-b583-429f1c8b2027

Office: https://www.keypedia.com/offices/new-orleans-district-office/95352142-b992-4e06-849d-d7483c0959ea