FDA WARNING_LETTER - Everett Laboratories, Inc

The FDA issued a Warning Letter to Everett Laboratories, Inc. on November 13, 2009, following an inspection of their contract manufacturer, (b)(4). The letter states that Everett Laboratories distributes drug products, including (b)(4) and (b)(4), manufactured by (b)(4).

These products are classified as "new drugs" under section 201(p) of the Federal Food, Drug, and Cosmetic Act (the Act) because they are not generally recognized as safe and effective. The FDA found no approved applications for these drug products, violating sections 301(d) and 505(a) of the Act, which require an approved application before a new drug can be introduced into interstate commerce.

Furthermore, the prescription drug products are misbranded under section 502(f)(1) of the Act because they lack adequate directions for use by a layman, as they are intended for conditions not amenable to self-diagnosis and treatment. The products are also deemed adulterated under 21 U.S.C. 351(a)(2)(B).

Everett Laboratories, Inc. was instructed to take prompt action to correct these violations and notify the FDA within fifteen working days of the specific steps taken, including documentation and a timeline for completion if corrective action cannot be completed within the specified period. Failure to comply may result in legal action, including seizure and injunction.