newman inc., ( – FDA Warning Letter, Dec 14, 2007

On December 4-7 and 14, 2007, an FDA inspection of Newman Inc., dba Medi-Stat, revealed serious violations of the Federal Food, Drug, and Cosmetic Act (FDCA). The firm, purporting to be a compounding pharmacy, was found to be manufacturing large volumes of standardized transdermal prescription products (e.g., KETO-STAT, NEURO-STAT) in anticipation of prescriptions, a practice inconsistent with traditional extemporaneous compounding. The firm's operations, including commercial-level distribution across multiple states, employment of sales representatives, and marketing with unproven claims, were deemed akin to a pharmaceutical manufacturer, thus exceeding the scope of traditional pharmacy compounding.

The firm's products are considered unapproved new drugs, violating Sections 505(a) and 301(d) of the FDCA, as no FDA-approved application is in effect. They are also misbranded under Sections 502(a), 502(f)(1), and 502(o) of the FDCA due to false/misleading labeling, lack of adequate directions for use, and failure to register the establishment and list products. Furthermore, the drug products are adulterated under Section 501(a)(2)(B) of the FDCA because manufacturing controls and procedures do not conform to Current Good Manufacturing Practice (CGMP) regulations (21 CFR 21