Vintage Pharmaceuticals LLC dba Qualitest Pharmaceuticals – FDA EIR, Jul 17, 2014

An FDA inspection was conducted at Vintage Pharmaceuticals LLC, operating as Qualitest Pharmaceuticals, in Huntsville, AL, from June 2 to July 17, 2014. This was a limited and directed inspection, not a general Good Manufacturing Practice (GMP) audit. The primary purpose was to assess the company's compliance with a January 10, 2014 Federal Register Notice. This notice detailed potential enforcement actions against firms producing or distributing specific unapproved drug products, including single-ingredient codeine sulfate oral tablets or solutions, codeine phosphate injection products, and certain fixed-dose combination products containing codeine phosphate or dihydrocodeine bitartrate.

During the inspection, Qualitest Pharmaceuticals was requested to provide a comprehensive list of its oral prescription drug products, including active ingredients, strengths, application numbers, and associated labeling. An FDA investigator conducted an initial review of the data and verified labeling for seven codeine-containing products in storage. The collected documentation was then submitted to the Center for Drug Evaluation and Research (CDER) for a thorough review. Upon CDER's confirmation that there were no concerns with the information provided, the inspection was formally concluded. The report explicitly stated that no violations were found regarding the unapproved drug products specified in the Federal Register Notice, and no further actions were required from the company.