Cohen, Dr. Richard Asheville, NC (2/9). Unapproved new drug, misbranded: According to product labeling on the Web site www.ocuzyme.com, it is intended to prevent, treat, or cure serious disease conditions such as protecting the eye against cataracts and for enhanced visions related to cataracts, glaucoma or other eye illnesses. Product labeling fails to bear adequate directions for its intended uses, etc. (OcuZyme); FDCA 352(f)(1) (05-ATL-07)
http://www.fda.gov/foi/warning_letters/g5277d.pdf
General Electric, Inc. Fairfield, CT (3/31). Inspected Salt Lake City, UT firm 11/15-12/1/04. QSR deviations, adulterated: Firm discovered that test technicians were not completing original test procedure documentation, but instead were copying test results from one device to another for at least one year. FDA found no indication that the firm conducted periodic checks or audits of the records to assure the data’s validity. The firm performed risk assessments for product failures without documenting how the severity or likelihood of occurrence used in the assessment was determined. The firm uses electronic database systems to document and track corrective and preventive actions, but the Corrective Action/Preventive Action System procedure does not reference the use of these database systems, or describe the steps necessary to close corrective and preventive actions, etc. (x-ray and fluoroscopic systems and accessories); FDCA 501(h), 502(t)(2), 21CFR 820.20(b)(3)(i), 820.100(a)(1)(2)(5), 820.75(a), 820.25(b), 820.198(a)(3), 820.198(e)(3)(6), 820.184(e), 820.90(b)(2), 820.70(b), 803, 806, 803.50(a)(2) (DEN-05-09)
http://www.fda.gov/foi/warning_letters/g5280d.pdf
Pfizer Inc. New York, NY (4/13). Misbranded: Three print ads make superiority claims about Zyrtec by suggesting it is clinically superior to some other allergy medicines. The print DTC ads claim that Zyrtec “works” and that at least some other allergy medicines do not work, etc. (Zyrtec); 21USC 352(n), 21CFR 202.1(e)(6) (No Code)
http://www.fda.gov/foi/warning_letters/g5286d.pdf
Presutti Laboratories Rolling Meadows, IL (3/30). Misbranded: A “Dear Doctor” letter for Tindamax submitted to FDA under Form FDA 2253. The letter is false or misleading because it suggests that Tindamax is safe and effective for uses for which it has not been approved by FDA. For example, by claiming that Tinadamax is the new replacement for metronidazole, which is approved to treat anaerobic bacterial infections, the letter suggests that Tinadamax is safe and effective for such infections. (Tindamax); FDCA 502(a), 502(f)(1) (No Code)
http://www.fda.gov/foi/warning_letters/g5278d.pdf
United Therapeutics Corp. Silver Spring, MD (4/13). Misbranded: A professional journal ad for Remodulin injection and a Medical Frequently Asked Questions booklet for the product are false and or misleading because they minimize risk information, make unsubstantiated effectiveness claims and omit material facts. (Remodulin); FDCA 352(a)(n), 321(n), 21CFR 202.1(e)(5)(i)(iii), e(6)(i), 201.100(d), 314.81(b)(3)(i) (No Code)
