Aurosal Pharmaceuticals Llc – FDA Warning Letter, May 24, 2012

The FDA issued a Warning Letter to Sal Pharma on April 24, 2012, due to the company's failure to fulfill drug establishment registration obligations under the Federal Food, Drug, and Cosmetic Act. The FDA's review indicated that Sal Pharma had not registered its establishment in 2011 or 2012, despite continuing to manufacture and import drugs into the United States.

This failure to register is a prohibited act under section 301(p) of the Act (21 U.S.C. § 331(p)). Additionally, drugs manufactured at an unregistered foreign establishment or not properly listed are subject to refusal of admission into the U.S. under sections 801(o) and 801(a)(3) of the Act, and may be considered misbranded under section 502(o).

Sal Pharma was instructed to immediately register its establishment and ensure proper listing of all drugs offered for import. A written response detailing corrective actions was required within fifteen working days. The letter also stated that notice of this violation might be provided to importers and consignees of record for affected drug shipments. The FDA emphasized that all registration and listing submissions must now be electronic via Structured Product Labeling (SPL).