ChiRhoClin, Inc. Burtonsville, MD (4/28). Inspected 2/9-13/04. Company failed to develop adequate written procedures for the surveillance and receipt of postmarketing adverse drug experiences. It also failed to submit all quarterly periodic adverse drug experience reports for Secreflo within 30 days of the close of the quarter (drug); FDCA 505(k), 21CFR 314.80(b)(c)(2) (04-BLT-19)
Clinical Pharmacies, Inc. Huntington Beach, CA (4/27). Inspected 2/19, 2/23, 3/1-2/04. QSR deviations, adulterated: Management with executive responsibility has not ensured that the quality policy is understood, implemented, and maintained at all levels of the organization. Clinical Pharmacies did not establish a quality plan defining the quality practices, resources, and activities relevant to devices that are designed and manufactured. It did not establish procedures for quality audits, for implementing corrective and preventive action, or for document control, etc. (dialysate concentrates); FDCA 501(h), 21CFR 820.5, 820.20(a)&(b)(3)&(c)&(d), 820.198(a)(1)(3), 820.22, 820.100(a)(1), 820.40, 820.50, 820.75(a), 820.90 (WL 36-04) http://www.fda.gov/foi/warning_letters/g4671d.pdf
Gano Excel U.S.A. Inc. Irwindale, CA (4/15). Reviewed Web site at www.ganoexcel.com. Misbranded: Labeling of products indicates that company intends to sell them as dietary supplements, but they express or make implied claims to prevent, treat, mitigate, cure, or diagnose a specific disease. (Ganoderma capsules, Excellium capsules, Gano Garcina capsules, Sakanno) (W/L 34-04) http://www.fda.gov/foi/warning_letters/g4673d.pdf
KNL Pharmaceutical Co. Great Neck, NY (5/4). Reviewed Web site at http://www.knlusa.com. Unapproved new drug. Claims cause product to be a drug. (Cancerfx170); FDCA 505 (No Code) http://www.fda.gov/foi/warning_letters/g4667d.pdf
White Lake Pharmacy White Lake, MI (1/16). Misbranded: Nicotine Lollipops are being marketed as shown on company’s Web site at www.whitelakecompounding.com. The product is sold without a prescription and is intended as an aid for smoking cessation or to reduce nicotine addiction (Nicotine Lollipops); FDCA 502(o), 510(j), 510, 502(f)(1)(2) (2004-DT-03) http://www.fda.gov/foi/warning_letters/g4674d.pdf
