FDA Enforcement In Brief
This article was originally published in The Tan Sheet
Executive Summary
Perrigo facility undergoes reinspection
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Perrigo facility undergoes reinspection Agency inspectors return to Perrigo's Allegan, Mich., manufacturing plant to follow up on an April 30, 2010, warning letter, the company says March 1. Following remediation, Allegan's output is back to full strength, though the private labeler had anticipated FDA's return to the facility before the end of 2010 (Also see "Perrigo Absorbs Plant Remediation Sales Hit, But PBM Progresses In Q1" - Pink Sheet, 8 Nov, 2010.). Sibutramine supplement recalled Svelte 30 Nutritional Consultants voluntarily recalls Svelte 30 orange and gray capsules after FDA notified the firm that the weight-loss products contain sibutramine, an Rx obesity drug ingredient withdrawn from the market after it was found to increase the risk of heart attack and stroke. The recalled lots were sold through the firm's Kissimmee, Fla., sales office on Jan. 3, 2011, but were not sold through the company's website. FDA cites protein products labels, GMPs Abba Pharma misbranded products, violated good manufacturing practices, made illegal drug claims and marketed an adulterated supplement, FDA says in a Feb. 9 letter. It cited evidence discovered during an August 2010 inspection. Several of the firm's protein products had higher levels of phosphorous, sodium and potassium than listed. The Tampa, Fla., firm's Nephronex liquid dietary supplement is an adulterated supplement because the firm failed to conduct appropriate batch and identity tests, among other GMP violations. The firm also makes illegal drug claims for Nephronex, Proteinex liquid predigested protein and ProteinexWound Care on labeling and online. Supplement firms cited for drug claims Millennium Bioceutics' and Ancient Formulas Inc.'s claims cause supplements to be marketed as drugs, FDA says in letters to the firms. In a Feb. 17 letter FDA says Delray Beach, Fla.-based Millennium makes anti-cancer claims for its Caplex Supplement. A Feb. 9 letter to Wichita, Kan.-based Ancient Formulas notes "labeling is not limited to the immediate product containers but includes all promotional literature which you distribute in connection with your products" and cites illegal claims for 13 products. One of Ancient Formula's products, Dyabet, is misbranded because it does not include capsule ingredients and does not have a supplement facts panel. |