Today FDA posted its latest batch of Warning Letters. They can be accessed in Adobe PDF format by clicking in the link following each letter.

Beehive Botanicals Hayward, WI (3/2). Inspected 11/14-15/06. Adulterated, misbranded: Claims in the product labeling such as “Bee Pollen Whole Grain(capsules, tablets, granules): It also destroys harmful bacteria in the intestines, …” cause the products to be unapproved new drugs. The company’s Web site shows that the products propolis 50% tincture, propolis 65% tincture, and propolis extract alcohol free may be used to treat skin eruptions, burns, cuts, and slow healing sores. These products are unapproved devices, etc. (standardized bee propolis dietary supplement, PropolPom Bee Propolis pomegranate dietary supplement, bee pollen whole grain dietary supplement, Royal Jelly dietary supplement, Propolis & herb throat spray, etc. ); FDCA 505, 501(f)(1)(B), 520(g), 502(o), 510(k), 403(a)(1) (MIN 07-15)

http://www.fda.gov/foi/warning_letters/b6276d.pdf

Newport Medical Instruments Costa Mesa, CA (2/21). Inspected 10/31-11/7/06. GMP deviations, adulterated: The responsibilities of the project team leader and members involved in the design project of the (purged) ventilator were not clearly described in the Design History File. The firm failed to have written procedures for changes made during product development. There were no records of retest and design reviews in the Design History File for the (purged) test in an Environmental Test Report. The procedure for product complaints does not describe the process of documenting and tracking failure investigations of the HT50 Homecare ventilators, etc. (ventilators); FDCA 501(h), 21CFR 820.30(b)& (e)&(f)& (i), 820.100(a), 820.22, 820.70(c), 820.72(a) (W/L 09-07)

http://www.fda.gov/foi/warning_letters/b6273d.pdf