Latest FDA Warning Letters
ATS Labs, LLC Houston, TX (2/3). GMP deviations, adulterated, misbranded: The firm performs the finished product labeling for Support, Liver Food, Test PSI, LipoBlast, CFI, Winalean, ProFiex, and Lady Lean products, but it stated during the inspection that it does not have specifications for these products. During the inspection the firm was unable to provide any written procedures for quality control operations. It also did not have an employee assigned to oversee quality control operations, etc. (dietary supplement products — Support, Liver Food, Test PSI, Lipo Blast, CFI, Dilate, Winalean, Pro Flex, Lady Lean, and Weapon-X PreWorkout Extreme); FDCA 402(g)(1), 402(f), 403(y), 21 CFR 111.70(f), 111.103, 111.255, 111.260, 111.415(f)(1), 111.70(g), 111.83(a), 111.553, 111 .453
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm485139.htm
Better Rx, LLC Houston, TX (2/2). Inspected 7/20-23/15. Unapproved new drugs, misbranded: The Soothee Patch (lidocaine 0.5%, menthol 5%, and methyl salicylate 2%), NDC 69592-001, labeled for topical “temporary relief of minor aches and muscle pains associated with arthritis, simple backache, strains, sprains, muscle soreness and stiffness” is a prescription drug under section FDCA 503(b)(1)(A) because, in light of its toxicity or potential for harmful effects, the method of its use, or the collateral measures necessary for its use, it is not safe for use except under the supervision of a practitioner licensed by law to administer it. Label fails to bear the symbol “Rx Only,” etc. (Soothee Patch); FDCA 502(f)(1), 503(b)(4)(A)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm485633.htm
Chaya Herbal Food Inc. Aguadilla, Puerto Rico (12/9/15). Reviewed Web site at www.chayaherbal.com 8/2015. Misbranded: The claims on the site establish that the firm’s Chaya Capsules, Chaya Tea, Chaya and Aloe Tea, and Sacha Inchi Omega 3-6-9 products are drugs. The products fail to bear adequate directions for their intended use, etc. (Chaya Capsules, Tea, Aloe Tea, Sacha Inchi Omega 3-6-9, Aloe Gelee and Foot Crème); FDCA FDCA 502(f)(1)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2015/ucm485270.htm
Majopa Industries, Corp. Guayama, PR (1/20). Inspected 7/30-8/11/15. Reviewed Web site www.graviolagroup.com 10/2015. GMP deviations, unapproved new drug, misbranded: The claims on the product label and the Web site establish that the product is a drug. For example, on the Web site it claims: “Watch real cancer patients testimonials about the use of Graviola extract and the benefits that it provided…” The investigator found that the firm did not prepare or follow master manufacturing record for any of its batches manufactured, etc. (Graviola extract); FDCA 505(a), 502(f)(1), 21 CFR 111.205(a), 111.70(d), 111.103, 111.70(b), 111.75(a)(1)(i), 111.95(b), 111.255(a), 111.8, 111.16, 111.153, 111.353, 111.453, 111.553
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm485275.htm
Tri-Med, Inc. (dba Advanced Care Infusion – Shelby) Shelby Township, MI (12/18). Inspected 2/12-2/23/15. Adulterated: The investigator observed serious deficiencies in the firm’s practices for producing sterile drug products. The firm’s operator touched non-sanitized equipment located outside of the ISO 5 laminar flow hood (LFH) area with their gloved hands and the operator’s gloves were not always appropriately sanitized with sterile (purged) before the gloved hands were placed under the ISO 5 LFH to perform aseptic manipulations. Also, the firm found fungus in the Buffer Room (ISO7) on 7/9/14 and did not identify the fungus and did not perform immediate remediation or an investigation into the cause, etc. (sterile drug products); FDCA 501(a)(2)(A)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2015/ucm486010.htm
Virbac Corp. North America Ft. Worth, TX (12/18/15). Inspected 10/29-12/30/14. GMP deviations, adulterated: The firm failed to establish and adequately staff a quality control unit capable of meeting the responsibilities outlined in 21 CFR 211.22. This is a repeat observation from 2007, 2008, and 2010 FDA inspections. Also, the firm failed to have written procedures covering significant responsibilities of the Quality Unit. The Quality Unit failed to prevent the release of animal drug products that fail to meet specifications. It also failed to conduct investigations and resolve all discrepancies/failures/deviations, and complaints, etc. (animal drugs); FDCA 501(a)(2)(B), 21 CFR 211.22, 211.165(f), 211.110(a), 211.142(b), 211.192, 211.198(a)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2015/ucm486141.htm