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.
Dechra Veterinary Products LLC Overland Park, KS (1/27) Unapproved new animal drug (levothyroxine products for dogs); FDCA 501 (a)(5)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm483676.htm
Diamond Animal Health Inc. Des Moines, IA (1/27) Unapproved new animal drug (levothyroxine products for dogs); FDCA 501 (a)(5)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm483679.htm
Kirkman Laboratories, Inc. Reno, NV (1/13). Inspected 6/3-24/15. Unapproved new drugs, misbranded (Flura-Drops Sodium Fluoride Drops, 2.21 mg, Perry Medical Fluorabon Drops USP, 0.25mg, 1.1 mg Cherry Dye-Free Sodium Fluoride Tablets, 2.21 mg Cherry Dye-Free Sodium Fluoride Tablets); FDCA 505(a), 505(b), 502(f)(l)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm483224.htm
Monmouth Medical Center Long Branch, NJ (11/10/15). Inspected IRB 4/1-20/15. FDA reviewed the FDA Establishment Inspection Report, the documents submitted with that report, and the IRB’s 5/1/15 written response and concluded that the IRB did not adhere to FDA regulations governing the protection of human subjects. The IRB failed to determine at the time of initial review that studies involving children are in compliance with 21 CFR part 50, subpart D, Additional Safeguards for Children in Clinical Investigations. It failed to review proposed research at convened meetings at which a majority of the members of the IRB are present, including at least one member whose primary concerns are in nonscientific areas. It also failed to prepare and maintain adequate documentation of IRB activities, including minutes of IRB meetings, etc. (clinical study); 21 CFR 56.109(h), 56.108(c), 56.115(a)(2), http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2015/ucm484164.htm
Neogen Corp. Lansing, MI (1/26) Unapproved new animal drug (levothyroxine products for dogs); FDCA 501 (a)(5)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm483391.htm
Quality Animal Care Manufacturing Lincoln, NE (1/26) Unapproved new animal drug (levothyroxine products for dogs); FDCA 501(a)(5)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm483404.htm
Terra Firma Botanicals, Inc. Eugene, OR (1/22). Inspected 3/10,11, 13, 17, 19/2015. CGMP violations, unapproved new drugs, misbranded: Claims on the firm’s Web site at www.terrafirmabotanicals.com establish that its products are drugs. For example, the site claims that Hawthorne Combo: “help regulate and balance the blood pressure” or that Milk Thistle: “rebuilds & regenerates damaged liver cells.” The firm markets YeastEaze Vaginal Suppositories and Horse Chestnut Varicose Away Spray as dietary supplements, but under FDCA 201(ff)(2)(A)(i) dietary supplements must be intended for ingestion, but according to the product labeling YeastEaze Vaginal Suppositories are intended for insertion into the body, and Horse Chestnut Varicose Away Spray is intended to be sprayed onto the body, etc. (Horse Chestnut Varicose Away Spray, YeastEaze Vaginal Suppositories, Hawthorne Combo, Skin Combo, Milk Thistle, Turmeric, Turmeric/Ginger Combination, Depress-Shun, Bliss, Candida and Fungus Away – Herbal Candida Relief, and Herp-Eaze Formula); 21 CFR 111.205(a), 111.70(b)(1), 111.75(a)(1)(i), 111.70(e), 111.103, 111.255(b)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm483218.htm
The One Minute Miracle, Inc. North Miami Beach, FL (12/11/15). Inspected 8/2015. Unapproved new drugs, misbranded: Miracle Diet 30 and Miracle Rock 48 are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or intended to affect the structure or function of the body and, thus, are drugs, etc. (Miracle Diet 30 and Miracle Rock 48); FDCA 502(f)(1), 502(a)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2015/ucm482980.htm
Virbac Animal Health, Inc. Fort Worth, TX (1/26) Unapproved new animal drug (levothyroxine products for dogs); FDCA 501 (a)(5)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm483374.htm