Dakotah International, Inc. Baton Rouge, LA (8/30). Inspected 3/26-4/3. Misbranded: Unapproved new drugs. The labeling for Dakotah’s products bear claims that refer to the cure, mitigation, or prevention of disease with statements such as “lowers cholesterol and blood triglyceride levels.” These claims cause the products to be drugs. The labels of several products do not bear the name and place of business of the manufacturer, packer or distributor, etc. (C-4, X-Treme fx, Herbelle, N.R.G., etc.); FDCA 505, 403(i)(1), 403(s)(2)(B), 101.3(d)(g), 403(q)(5)(F) (2002-NOL-43)
http://www.fda.gov/foi/warning_letters/g3494d.pdf
Movingpeople.net Helmond, The Netherlands (9/10). Collected information 5/28-30. Products manufactured at Toronto, Canada facility: QSR deviations, adulterated, misbranded: There are no written procedures for management review and internal audits. No internal audits of the quality system have been performed in the last year. There are no procedures for training or documentation that any employee has been trained in the manufacturing operations. Incoming acceptance activities are not performed on incoming components and no Certificates of Analysis are received from vendors of components, for the Fortress Model 2000 and 1704 scooter devices, etc. (Fortress Model 1700, 1704, 2000, and 2001 Power Scooters, Corsaire Power Chair); FDCA 501(h), 502(t)(2), 21CFR 820.20(c ), 820.22, 820.25, 820.50, 820.80(b), 820.100(a), 820.198(a), 820.200(b), 803.17 (No Code)
http://www.fda.gov/foi/warning_letters/g3497d.pdf
Unit Dose Packaging, Inc. Phoenix, AZ (8/29). Inspected 4/23-24. GMP deviations, adulterated, misbranded: There are no employees in the firm designated as a quality control person. No activities were observed that would reflect any independent review, test, and/or approval of any aspects of the drug manufacturing operations. The FDA investigator observed that there was no finished product testing for any of the 17 different topical anesthetic drug products for necessary chemical or microbiological requirements. Follow-up on a complaint received 5/31/99 reporting an ineffective product did not include test of retained product for the potency of the active ingredient, etc. (finished pharmaceuticals); FDCA 501(a)(2)(B), 501(c), 502(a), 211.22(a), 211.165(a), 211.84(d)(1), 211.100(a), 211.198(a), 211.166(a), 211.68(a) (W/L 42-02)
http://www.fda.gov/foi/warning_letters/g3490d.pdf
Upsher-Smith Laboratories Plymouth, MN (9/6). Promotional literature collected 3/13-14. Misbranded, unapproved new drug: Literature contains claims for the treatment, prevention, and mitigation of the disease, hypercholesterolemia. (Slo-Niacin); FDCA 502(f)(1), 505(a) (MIN 02-43)
