Today FDA posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter.
Ageless Aesthetics, Inc. Aurora, CO (7/18). Reviewed Web site at the http://medik8.us/ in June. Some of the Web site claims that provide evidence that the products are intended for use as drugs include a claim for White Balance Click Intense Brightening Serum that is has “proven significant whitening activity of 97.3%.” The products are not generally recognized as safe and effective for the referenced uses and are therefore “new drugs,” etc. (White Balance ClickM Intense Brightening Serum, White Balance Click Oxy-R Ultra Brightening Serum, and Growth Factor); FDCA 505(a)
Annmarie Gianni Skin Care Orange, CT (7/15). Reviewed the firm’s Web site at http://www.annmariegianni.com/ in May. The claims on the Web site establish that the products are drugs. For example, the site makes the claim for Repair Serum that “Using vegan stem cells…a new way for your skin to build collagen, repair itself and prevent aging.” It also claims for Anti-Aging Serum that “This serum will increase skin hydration by inhibiting hyalurondase…,” etc. (Repair Serum, Anti-Aging Eye Cream, and Anti-Aging Serum) FDCA 505(a)
Diabetes Corporation of America Franklin, TN (6/3). Inspected 8/11-14 and 8/17-20/15. Adulterated: FDA investigators observed serious deficiencies in the firm’s practices for producing sterile drug products. It did not depyrogenate the container closures of injectable finished drug products. Also investigators observed sterilized glass vials stored in the anteroom without an established hold time to ensure these items remain sterile. The firm did not use a sporicidal agent to disinfect the aseptic processing area, etc. (sterile drug products); FDCA 501(a)(2)(A)
Health Innovations Pharmacy, Inc. Southern Pines, NC (7/8). Inspected 2/23-27/15. CGMP violations, adulterated, misbranded: The firm failed to conduct personnel monitoring, and did not use a sporicidal agent as part of the disinfection program for the cleanroom and ISO 5 area. Also the facility lacked magnehelic gauges to monitor pressure differentials between the ISO 7 cleanroom and the anteroom. FDA’s investigators noted that the firm was not receiving valid prescriptions for individually identified patients for a portion of the drug products it was producing, etc. (drug products); FDCA 502(f)(l), 501(a)(2)(A), 21 CFR 211.42(c)(10)(v), 211.113(b), 211.167(a), 211.166(a), 211.42(c)(10)(iv)
Karen Roche Be Green Bath and Body North Easton, MA (7/15). Reviewed Web site at http://begreenbathandbody.com/ in May. Misbranded: The products offered on the site are drugs because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease. For example, the site makes the claim for Evening Primrose Healing Oil: “Natural relief for eczema flare-ups.” The Rose Hip Scar Oil Treatment product is intended for treatment of one or more diseases that are not amenable to self-diagnosis or treatment without the supervision of a licensed practitioner. It is impossible to write adequate directions for a layperson to use the product safely for its intended purposes, etc. (Rose Hip Scar Oil Treatment, Evening Primrose Healing Oil, Organic Shea Butter Tin, and Calendula Cream); FDCA 502(f)(1)