FDA WARNING_LETTER - J & F International, Inc. - April 09, 2009

On April 7-9, 2009, the FDA inspected J & F International Inc., dba Alexandria Medical Arts Pharmacy & Compounding Laboratory, and documented serious violations of the Federal Food, Drug, and Cosmetic Act (FDCA). The firm was found to have compounded domperidone products for human patients on numerous occasions between November 2008 and April 2009.

The FDA considers domperidone compounding inappropriate due to public health risks, including cardiac arrhythmias, cardiac arrest, and sudden death, and its unapproved use for increasing breast milk production. Domperidone is not a component of an FDA-approved drug, nor is it subject to a USP or NF monograph, making compounded products ineligible for exemptions under FDCA Section 503A.

The compounded domperidone products are considered "new drugs" under FDCA Section 201(p) because they are not generally recognized as safe and effective. Their introduction into interstate commerce violates FDCA Sections 301(d) and 505(a) as no approved application is in effect. Furthermore, these products are misbranded under FDCA Section 502(f)(1) for lacking adequate directions for use and are not exempt from this requirement.

The FDA requires prompt corrective action to address these violations. Failure to comply may result in legal action, including seizure and injunction. The firm must respond within fifteen working days, detailing corrective steps