Warning Letter Bulletin back issues from April 2006:
Affordable supplements (also dba Legal Gear), Northborough, MA, March 8 (CFSAN).(HUMAN DRUGS & DIETARY SUPPLEMENTS: CFSAN objects to companies' promotions of synthetic steroids)
Apr 01, 2006 ... Center for Food Safety and Applied Nutrition (CFSAN) reviewed the firm's marketing of the product Legal Gear Methyl 1-P--which names 6-alpha-methyl-etiocholene-3,17-dione and 17ahydroxyprogesterone--on the product's label and on Affordable Supplements's Internet website. According to the ...
Anabolic resources (also dba Supplementstogo.com), Gilbert, AZ, March 8 (CFSAN).(HUMAN DRUGS & DIETARY SUPPLEMENTS: CFSAN objects to companies' promotions of synthetic steroids)
Apr 01, 2006 ... CFSAN objected to the company's product Anabolic Xtreme Superdrol, which contains the synthetic steroid, methasteron. According to the warning letter, the labeling and website initially included unsubstantiated statements about Anabolic Xtreme Superdrol, such as, "many people ...
Legal gear (also dba Affordable Supplements), Northborough, MA, March 8 (CFSAN).(HUMAN DRUGS & DIETARY SUPPLEMENTS: CFSAN objects to companies' promotions of synthetic steroids)
Apr 01, 2006 ... [See story under Affordable Supplements, Doc ....
Supplementstogo.com, (dba as Anabolic Resources), Cincinnati, March 8 (CFSAN).(HUMAN DRUGS & DIETARY SUPPLEMENTS: CFSAN objects to companies' promotions of synthetic steroids)
Apr 01, 2006 ... [See story under Anabolic Resources, ...
Merazon Health Products, Seattle, March 1 (Seattle).(HUMAN DRUGS & DIETARY SUPPLEMENTS: CFSAN objects to companies' promotions of synthetic steroids)
Apr 01, 2006 ... In conjunction with an inspection on Nov. 9, 15 and 18, 2005, FDA reviewed the firm's three websites and found violations of the Federal Food, Drug and Cosmetic Act. First of all, Merazon was promoting its products as intended for use in the diagnosis, cure, mitigation, ...
North American Herb & Spice, Waukegan, IL, March 22 (Chicago).(HUMAN DRUGS & DIETARY SUPPLEMENTS: CFSAN objects to companies' promotions of synthetic steroids)
Apr 01, 2006 ... FDA reviewed the company's two websites and concluded that its product--kid e kare Cold & Flu Gelcaps--was being promoted as a drug for which no NDA was submitted. Specifically, North ...
Water Oz, Grangeville, ID, March 8 (Seattle).(HUMAN DRUGS & DIETARY SUPPLEMENTS: CFSAN objects to companies' promotions of synthetic steroids)
Apr 01, 2006 ... FDA reviewed the Water Oz website and determined that it was promoting its products for use in the diagnosis, cure, mitigation, treatment and prevention of diseases, which would make the products drugs for which no NDAs were submitted. Unsubstantiated claims regarding the firm's ...
Health-Marketplace.com, Columbia, MD, Jan. 30 (CFSAN).(CFSAN UNTITLED LETTERS)
Apr 01, 2006 ... CFSAN reviewed the firm's website and determined that the products Life Extension Shark Cartilage Capsules, Tonalin CLA and Chromium Picolinate were being promoted for conditions that caused them to be products, for which no NDAs had been filed. Unsubstantiated therapeutic ...
Life's Vigor Health and Beauty Care, Bakersfield, CA, Jan. 24 (CFSAN).(CFSAN UNTITLED LETTERS)
Apr 01, 2006 ... FDA reviewed the firm's website and determined that the products Only Natural 99% Pure DHEA and CC Pollen 24-Hour Royal Jelly 150mg with Bee Pollen were being promoted for conditions that caused them to be products to be drugs, for which no NDAs had been filed. Unsubstantiated ...
EEMSO, Inc., (formerly Shevlin Medical), Dallas, March 30 (Dallas).(MEDICAL DEVICES)
Apr 01, 2006 ... On Jan. 24 and 31, and Feb. 1 and 16, FDA conducted an inspection of EEMSO and determined the firm acts as a specification developer and an importer for the E-Strip Disposable lontophoretic Treatment System and the High Voltage Galvanic Stimulator (HVGS) Model 9000 and 9000 Il, and as an ...
General Atomics, Diazyme Labs Division, San Diego (March 13) Los Angeles.(MEDICAL DEVICES)
Apr 01, 2006 ... An Oct. 31 to Nov. 9, 2005, investigation at the firm's Brea, CA-facility, determined the manufacturer of in vitro diagnostic devices was not in conformance with the GMP requirements of the QS Regulation, as regarded the firm's methods used in, and the facilities or controls used for, ...
In Vivo Metric Systems Corp., Heraldsburg, CA, March 17 (San Francisco).(MEDICAL DEVICES)
Apr 01, 2006 ... A Sept. 13-30, 2005, FDA investigation of the manufacturer of cutaneous electrodes indicated the firm was not in conformance with the GMP requirements of the QS Regulations for medical devices. Significant deviations included, but were not limited to failure to define, document ...
MicroSurgical Technologies, Redmond, WA, March 1 (Seattle).(MEDICAL DEVICES)
Apr 01, 2006 ... A Nov. 8-10, 14-16 and 21, 2005, FDA investigation conducted at the manufacturer of two ophthalmic surgical devices--Phaco Needles and Tips and the Oculo-Pressor--determined MicroSurgical was not in conformance with current GMP requirements of the QS Regulation. MicroSurgical ...
PML Microbiologicals, Wilsonville, OR, March 16 (Seattle).(MEDICAL DEVICES)
Apr 01, 2006 ... FDA conducted an inspection--of the manufacturer, labeler and distributor of four biological testing devices--on Nov. 7-10 and 14-15, 2005. The investigator determined the first three devices--the M0020, M0021, and M0022--were intended for use in testing the antimicrobial susceptibility of ...
VaxGen, Brisbane, CA, March 24 (CBER).(BLOOD/BIOLOGICALS)
Apr 01, 2006 ... FDA's Center for Biologics reviewed a Question and Answer (Q&A) document distributed by the firm's sales representatives at a promotional booth in connection with the 4'h Annual Federal Biodefense Research FY 2006 meeting, Oct. 17-19, 2005, in Washington, regarding VaxGen's investigational ...
Agile Radiological Technologies, Cincinnati, March 17 (Cincinnati).(RADIOLOGICALS)
Apr 01, 2006 ... An FDA investigation, conducted between Jan. 17 and 27, revealed the manufacturer of the Radiation Analyzer (RAy) Film Dosimetry software product was not in conformance with the current GMP requirements of the QS regulations. Significant deviations included, but were not limited ...
John Brown, M.D., Riley's Children's Hospital, Indianapolis, March 27 (CDRH).(RADIOLOGICALS)
Apr 01, 2006 ... In the warning letter, CDRH did not indicate the dates it visited Brown's clinical site to determine whether activities and procedures related to Brown's participation in the clinical study of an unnamed radiological device complied with applicable federal regulations. However, ...
David G. Greenhalgh, M.D., Chief of Burns, Shriners Hospitals for Children Northern California, Sacramento, CA, March 6 (CDRH).(RADIOLOGICALS)
Apr 01, 2006 ... CDRH informed Greenhalgh of objectionable conditions observed during an FDA inspection conducted at his clinical site from Sept. 2-Oct. 27, 2005. The purpose of the inspection was to determine whether Greenhalgh's activities and procedures related to participation in the clinical study of ...
Paul Fenster, M.D., University of Arizona, Tucson, AZ, March 21 (CDRH).(RADIOLOGICALS)
Apr 01, 2006 ... An FDA inspection was conducted at Fenster's clinical site Oct. 3-Nov. 22, 2005, to determine whether Fenster's activities and procedures related to his participation in the clinical study for an unnamed radiological device complied with applicable federal regulations. FDA ...