Latest FDA Warning Letters
Today FDA posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter.
Adamson Analytical Laboratories, Inc. Corona, CA (8/2). Inspected 8/4-14/15. CGMP deviations, adulterated: The high performance liquid chromatography (HPLC) and gas chromatography (GC) data acquisition systems did not have sufficient controls to prevent deletion or alteration of raw data files. During the inspection, FDA investigators observed that the laboratory personnel use a shared password to access the HPLC (purged) computer system and that the GC (purged) computer system requires no password for access. Multiple instruments had no audit trail function to record information about each analytical test, etc. (finished pharmaceuticals); 21 CFR 211.68(b), 211.160(b)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm514910.htm
Concept Products Limited Tianjin, China (7/26). Inspected 8/3-5/15. CGMP deviations, adulterated: The firm does not have, for each batch of drug product, appropriate laboratory determination of satisfactory conformance to final specifications for the drug product, including the identity and strength of each active ingredient. The firm failed to establish and follow written procedures for cleaning and maintenance of equipment used in the manufacturing, processing, packaging or holding of a drug product, etc. (finished pharmaceuticals); 21 CFR 211.165(a), 211.84(a), 211.166(a), 211.100(a), 211.67(b)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm514420.htm
Fallon Wellness Pharmacy, LLC Latham, NY (2/1). Inspected 3/2-10/15. Investigators noted that the firm was not receiving valid prescriptions for individually-identified patients for a portion of the drug products it was producing. Also, the investigators observed serious deficiencies in the firm’s practices for producing sterile drug products. Adulterated, misbranded: The firm did not take remedial action when viable air samples tested positive for fungus on various dates in one of its cleanrooms during a (purged) cleanroom certification. It also firm failed to establish an adequate system for maintaining equipment used to control aseptic conditions, etc. (drug products); FDCA 501(a)(2)(A)(B), 502(f)(1), 21 CFR 211.113(b), 211.42(c)(10)( iv)(vi), 211.28(a), 211.166(a), 211.167(a)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm515175.htm
Finally Pure, LLC Wasilla, AL (7/20). Reviewed Web site at www.finallypure.com in May.
The claims on the Web site establish that the products are drugs. The products are not generally recognized as safe and effective for the referenced uses and, therefore, the products are “new drugs;” (Toner for All Skin Types, Unscented Day Cream for All Skin Types, Unscented Day Cream for Extra Sensitive Skin, Unscented Day Cream for Dry/Mature Skin, and Lemongrass Herbal Sore Muscle Massage Oil); FDCA 505(a)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm515125.htm
John D. Gabriel, MD North Hills Medical Research, Inc. North Richland Hills, TX (6/28). Inspected 2/1-18. Clinical investigator violations: The investigational plan requires that the investigator delay randomization for subjects who do not have key laboratory data by the end of Visit 1, but the investigator failed to adhere to these requirements. Subjects 110946 and 112166 were initially overdosed with study drug because the investigator did not have required serum creatinine and eGFR values at the time the subjects were randomized and received study drug. FDA is unable to undertake an informed evaluation of the investigator’s written response because he did not provide a corrective action plan that, if properly carried out, would prevent this type of violation in the future, etc. (drug study); 21 CFR 312.60
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm514413.htm
MiN New York New York, NY (7/28). Reviewed Web site at http://min.com/ in May and again in July. The claims on the site establish that the products are unapproved new drugs. For example, the site makes claims for Calming Facial Oil such as: “Neroli promotes cell growth.” and “Myrrh has anti-inflammatory and anti-anxiety properties…and have anti-bacterial properties,” etc. (Calming Facial Oil, ProEnzyme Facial Cleanser, ProEnzyme Facial Scrub, and Complex Age Defying Moisturizer); FDCA 505(a)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm515078.htm
Plainsboro Pharmacy Plainsboro, NJ (8/1). Inspected 7/30/14. Misbranded: FDA received a MedWatch report dated 7/17/14, regarding an adverse event reportedly experienced by a patient who received sustained release liothyronine (T3) capsules prepared by the firm. FDA analysis of a sample of the product received from the patient found that it contained approximately 2.3 mg of liothyronine per capsule, which far exceeds the label claim. (liothyronine); FDCA 502(a)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm514665.htm
Viva Nutraceuticals J & E International Corp.Ferndale, WA (7/22). Reviewed Web site at www.vivahealthsolutions.com in June and promotional materials distributed at the 2016 Natural Products Expo West trade show 3/9-13. Misbranded: The claims on the site and promotional material establish that these products are drugs. For example, on the Web page entitled “Golden Omega-3 Max” it claims “Lowers blood pressure in hypertensive individuals” and “Lowers cholesterol levels,” etc. (Eyestonia, Ginkgo Biloba 60mg, Golden Omega-3 Max, Indole-3-Carbinol 200mg, Liveria, L-Lysine 1000mg, and ProsTac Softgel); FDCA 502(f)(1)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm515082.htm
Lavian Ltd. Hicksville, NY (7/22). Reviewed Web site at http://dermelect.com/ in May and again in July. The claims on the site establish that the products are drugs. The products are not generally recognized as safe and effective for the referenced uses and therefore the products are “new drugs” (Smooth Lip Volumizer, Empower MP6 Anti-Wrinkle Treatment, and Resurgent Stem Cell Firming Activator); FDCA 505(a)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm514904.htm
Peter Thomas Roth Labs, LLC New York, NY (7/22). Reviewed Web site at https://www.peterthomasroth.com/ in May and again in July. The claims on the site establish that the products are unapproved new drugs. For example, the site claims for Un-Wrinkle Turbo Line Smoothing Toning Lotion: “A blend of 18 neuropeptides and peptides – work to help send signals to skin to help activate anti-aging mechanisms that help the appearance of deep wrinkles and expression lines,” etc. (Un-Wrinkle Turbo Line Smoothing Toning Lotion, and Mega-Rich Intensive Anti-Aging Cellular Eye Crème); FDCA 505(a)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm514902.htm
TPR Holdings, LLC New York, NY (7/22). Reviewed Web site at http://www.freeze247.com/ in May and again in July. Unapproved new drug (Freeze 24-7 Instant Targeted Wrinkle Treatment product); FDCA 505(a)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm514901.htm