FDA Seeks Injunction for GMP Violations

WASHINGTONAfter finding repeated violations of cGMPs (current good manufacturing practices), FDA is seeking an injunction requiring Kabco Pharmaceuticals Inc., and owner Abu Kabir, of Amityville, NY, to stop producing and distributing dietary supplements. The agency wants the company to show it complies with cGMPs and the Federal Food, Drug and Cosmetic Act before it is allowed to start operations again.

The complaint was filed in the U.S. District Court for the Eastern District of New York. If entered, the injunction would require Kabco to stop manufacturing and distributing dietary supplements until, among other corrective actions, the company demonstrates to FDA that it is meeting the quality, safety, and labeling standards required by law.

According to a warning letter the agency sent to the company in 2010, FDA inspections found Kabco distributed supplements that did not meet product specifications. The company did not review and investigate product complaints, and Kabco also failed to hold dietary supplements under conditions designed to prevent product mix-ups.

The dietary supplements produced by Kabco Pharmaceuticals include Brewers Yeast Tablets, Dandelion Root Capsules, Night-Time Herb Capsules, Inositol Calcium & Magnesium Capsules, Vitamin C-500 with Rose Hips Time Released Tablets and Joint All Capsules.

Learn from others' GMP mistakes by viewing the INSIDER slide show: Top Ten Warning Letter Lessons.