Compounding pharmacies continue to receive citations from the FDA (both Form FDA 483s and Warning Letters) for a continuing failure to meet 21 CFR 210/211 requirements. All one needs to do is visit FDA’s Electronic Reading Room to learn of the ORA audits and the subsequent citations. Even after the New England Compounding Center … [Read more...]
JUBILANT HOLLISTERSTIER, LLC RECEIVES WARNING LETTER (11/27/13)
FIRM FAILS TO ASSURE ADEQUATE USE OF SPORICIDAL AGENTS AND CLEANING SUPPLIES Jubilant HollisterStier, Spokane, WA was audited by the FDA between April 15 and May 10, 2013. The FDA reviewed the firm’s response from May 30 and noted that sufficient corrections actions were lacking. The FDA also received additional correspondence dated July 12 and August 15, but believed that a … [Read more...]
