FDA WARNING_LETTER - Deston Therapeutics, LLC.

This FDA Warning Letter (10-ATL-08) was issued to David M. Preston, CEO of Deston Therapeutics, LLC, following an FDA inspection of a contract manufacturer, (b)(4), in (b)(4) 2009. The letter states that Deston Therapeutics contracted with (b)(4) to manufacture and distribute drug products, including Novahistine DH CIII Liquid and Aquatab C Tablets.

These products are deemed "new drugs" under section 201(p) of the Act because they are not generally recognized as safe and effective. Consequently, their introduction into interstate commerce without FDA-approved applications violates sections 301(d) and 505(a) of the Act. Furthermore, as prescription drugs intended for conditions not amenable to self-diagnosis, they lack adequate directions for lay use, rendering them misbranded under section 502(f)(1) of the Act. The letter also states that these products are adulterated under 21 U.S.C. 351(a)(2)(B).

Deston Therapeutics is responsible for investigating and correcting these violations, which are not limited to products manufactured by (b)(4). The firm must respond within fifteen working days, detailing corrective actions, preventative measures, and supporting documentation. Failure to comply may result in legal action, including seizure and injunction, and may impact future federal contracts.