Sovereign Pharmaceuticals, LLC – FDA Warning Letter, Feb 2, 2012

The FDA issued a Warning Letter to Sovereign Pharmaceuticals, LLC following a January 18 - February 2, 2012, inspection of their Fort Worth, TX pharmaceutical contract manufacturing facility. The inspection revealed significant violations of current Good Manufacturing Practice (CGMP) regulations (21 CFR Parts 210 and 211), rendering their drug products adulterated. Additionally, the firm was found to be marketing unapproved new drugs and/or misbranded drugs. CGMP violations included the firm's failure to thoroughly investigate batch failures, such as content uniformity and out-of-specification yields (21 CFR § 211.192), and the lack of established written procedures to monitor manufacturing processes for variability, specifically regarding in-process blend uniformity testing (21 CFR § 211.110(a)). The FDA noted that the firm's previous response lacked sufficient corrective actions. Furthermore, several over-the-counter products, including Certuss, Certuss-D, Trexbrom, Tekral, Rescon GG, Rescon, and Rescon OM, were identified as unapproved new drugs because they do not comply with monograph requirements and are not generally recognized as safe and effective. Specific issues included incompatible active ingredient combinations, incorrect dosing for active ingredients, and unacceptable indications. Rescon GG was also misbranded for lacking required warnings (Section 502(f)(2)), and Liquibid D-R was misbranded due to a misleading principal display panel (Section 502(a)). The FDA requires prompt corrective actions within fifteen working days, warning that failure to comply could lead to legal action, including seizure and injunction, and impact future contracts or drug application approvals.