Today FDA posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter.
The Avalon Effect, Inc. Franklin, TN (11/5). The firm is marketing the Quantum Series Personal Wellness Pack in the United States without marketing clearance or approval. FDA’s review of the Tumblr site at www.theavaloneffect.tumblr.com and the firm’s Facebook site found “device” claims for the Quantum Series Personal Wellness Pack such as “Fungal meningitis,” “MRSA,” and “Concussions.” (the Quantum series); FDCA 501(f)(1)(B)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2012/ucm327202.htm
Health Breakthroughs International, LLC Beaverton, OR (10/22). Inspected 5/29- 30 and 6/6-7. Misbranded: The products are promoted for conditions that cause them to be unapproved new drugs. Examples of some of the claims observed on the Web site www.healthbreakthroughs.net include: “Amazing C: Vitamin C [an ingredient in your product] ... heal the small intestines.” The Web site www.Odisease.com contains disease claims in the form of personal testimonials which establish that these products are intended for use as drugs. The Power Herbal Formula product is misbranded within the meaning of section 403(s)(2)(C) in that the product label fails to identify the part of the plant from which an ingredient is derived in the ingredient statement or in the nutrition label as required, etc. (Amazing C, MPS-Gold 100, and Power Herbal Formula); FDCA 403(s)(2)(B), 403(s)(2)(C), 403(i)(2), 403(q)(5)(F)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2012/ucm327303.htm
I. Shay Cosmetics, Inc. Gardena, CA (10/22). Inspected 2/1-29. GMP deviations, adulterated, misbranded: The firm’s water testing program is not based on scientifically sound methodology and has the potential for masking microbiological contamination. There is no assurance it is of adequate quality for drug manufacturing. The firm has not cleaned and maintained equipment at appropriate intervals to prevent contamination that would alter the safety, identity, strength, or quality of the drug product, etc. (finished pharmaceuticals); FDCA 501 (a)(2)(B), 502(c), 21 CFR 211.160(b), 211.100(a), 211.67(a), 211.166(a), 211.84(d)(2)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2012/ucm327498.htm
Mushroom Wisdom, Inc. East Rutherford, NJ (10/18). Inspected 4/2-4/30. The products are labeled for conditions that cause them to be drugs. Also the dietary supplements have been prepared, packed, or held under conditions that do not meet the CGMP in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements regulation. Although the firm sent out samples of finished product lots to outside laboratories for testing, the laboratories only tested for heavy metals (mercury, lead, arsenic, and cadmium) and food chemistry (ash, total calories, total carbohydrates, fat, moisture, and protein); instead of conducting assay tests to determine that the components were consistent with your firm’s established specifications, etc. (Amyloban 3399 From Lion’s Mane, Grifron Maitake, and Super Shiitake); FDCA 505(a), 21 CFR 111.75, 111.560(a)(2), 111.325(b)(1), 111.535(b)(2), 111.160(d)(1), 111.160(c)(3), 111.35(b)(4).
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2012/ucm325553.htm
Westone Laboratories Inc. Colorado Springs, CO (10/23). Inspected 7/2, 10, and 12. QSR deviations, adulterated: The firm failed to evaluate potential suppliers on the basis of their ability to meet specified requirements for Oto-Ease, establish or maintain records of acceptable suppliers of Oto-Ease packaging materials or contract manufacturers of lubricant; and establish or maintain data that clearly describe or reference the specified requirements, including quality requirements. It also failed to maintain complaint files and establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit, etc. (Oto-Ease, a patient lubricant); FDCA 501(h), 501(f)(1)(B), 515(a), 21 CFR 820.50, 820.198(a), 820.80(a), 820.70(c), 820.70(g)(1), 820.60, 820.40, 820.181, 820.184, 820.25(b)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2012/ucm326927.htm
