FDA to Braintree Labs: Too many bug parts in your laxatives

FDA to Braintree Labs: Too many bug parts in your laxatives

The U.S. Food and Drug Administration has issued a second warning to Braintree Laboratories, the maker of the laxative Miralax and other gastrointestinal drugs, after insect parts were found in some of its products.

The letter states that during inspections in December and January, FDA officials found significant violations of Current Good Manufacturing Practice regulations. The FDA instructed the Braintree, Mass.-based company to take corrective action at that point. The facility where the inspections occurred is in Holbrook, Mass.

The FDA said that it was unsatisfied with the company’s efforts to resolve the problems, detailed in letters back to the FDA on Feb. 10 and March 19.

The FDA’s second letter says the company received 21 consumer complaints about foreign material, in this case insects, insect parts and spiders, in five finished products. The FDA claims that the company did not do a thorough investigation to figure out whether contaminated raw materials, or facility problems were to blame.

More:
http://www.bizjournals.com/boston/stories/2010/05/17/daily30.html?ana=from_rss

well.... you know....