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.
ABC Productions Redondo Beach, CA (2/4). Reviewed Web site at www.calistores.com and www.cbdy.com in January. Misbranded: The claims on the Web sites establish that these products are drugs, etc. (CBDy CBD Drops, Unflavored Hemp Oil Supplement, Cannabidiol Tincture, Hermosa Farm CannaHoney CBD, Cannabidiol Honey CBD 6oz); FDCA 505, 502(f)(1)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm484989.htm
AnazaoHealth Corp. Las Vegas, NV (12/9/15) Inspected 1/20-30/15. CGMP violations, adulterated: Some of the drug products do not include the following information on the product labels: the statements, “This is a compounded drug” and “Not for resale,” the lot or batch number, the dosage form, the date that the drug was compounded, and storage and handling instructions. Not all bulk drug substances used by this facility to compound drug products are manufactured by an establishment that is registered under section 510, etc. (sterile drug products); FDCA 505, 502(f)(1), 501(a)(2)(A)&(B), 21 CFR 211.113(b), 211.42(c)(10)(v), 211.160(b), 211.192
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2015/ucm484896.htm
Bateman's Mosida Farms LLC Spanish Fork, UT (1/12). Adulterated: The practice caused the new animal drug (purged) (ceftiofur hydrochloride) to be unsafe. It did not comply with the regulations for Extralabel Drug Use in Animals. The actions resulted in an animal being offered for sale for slaughter as food that was adulterated. (ceftiofur HCl); FDCA 501(a)(5)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm484872.htm
Calwood Nutritionals, LLC Sykesville, MD (2/2). FDA collected samples and reviewed the firm’s Web site at www.calwoodnutritionals.com. Unapproved new drug: The claims on the Web site and in the brochures establish that its products are drugs because they are intended for use in the cure, mitigation, treatment, or prevention of disease. (Amino Acid products Nutramine-Amino Bites; Nutramine; Nutrasentials Drink Mix; and DialysAid)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm484876.htm
Dose of Nature Provo, UT (2/4). Reviewed Web sites at www.doseofnature.com, www.healthydoseofnature.com, and www.puredoseofnature.com, in January. The claims on the Web sites establish that the firm’s products are drugs, etc. (Red Strap Hemp Extract Quick FX 1x - 288mg, Red Strap Hemp Extract Quick FX 4x – 1088mg, RedStrap 2000 mg Hemp Extract – Clinical Grade, RedStrap 250 mg Hemp Extract – Clinical Grade, RedStrap 500 mg Hemp Extract – Clinical Grade, etc.)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm484970.htm
Green Garden Gold, LLC Dallas, TX (2/4). Reviewed the firm’s Web site at www.GreenGardenGold.com and its social media sites in January. The claims on the Web site establish that Regular CBD-Oil 100mg and CBD Strawberry Jam products are drugs because they are intended for use in the cure, mitigation, treatment, or prevention of disease, etc. (Regular CBD-Oil 100mg and CBD Strawberry Jam); FDCA 505(a), 502(f)(1)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm484947.htm
HealthyHempOil.com Austin, TX (2/4). Reviewed the firm’s Web site at www.healthyhempoil.com and its social media sites in January. The claims on the sites establish that the products are drugs (Herbal Renewals Gold CBD Oil, Herbal Renewals CBD Oil Spray); FDCA 505
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm484968.htm
Ipca Laboratories Ltd. Kandivli (West), Mumbai, India (1/29). Inspected three Ipca pharmaceutical manufacturing facilities. 7/14-18, 10/13-17, 12/1-19. GMP deviations, adulterated: At the Ratlam facility the firm failed to have computerized systems with sufficient controls to prevent unauthorized access or changes to data. At the Pithampur facility the firm failed to ensure that laboratory records include complete data derived from all tests necessary to assure compliance with established specifications and standards. FDA also found multiple instances of trial injections of samples. The results of additional tests were reported, but the original (trial) results were not. At Piparia Silvassa, FDA documented that the QC laboratory was conducting trial injections of samples but failed to report all of the data generated, etc. (active pharmaceutical ingredients); FDCA 501(a)(2)(B), 21 CFR 211.194(a), 211.160 (b)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm484910.htm
Michigan Herbal Remedies Rockford, MI dba Tasty Hemp Oil, dba US Hemp Wholesale, dba Alternate Vape (2/4). Unapproved new drug products (Bluebird Botanicals Bulletproof CBD Blend, US Hemp Wholesale 25% CBD Hemp Oil Supplement (aka “Gold Label CBD Hemp Oil”), Plus CBD Oil, Endoca Hemp Oil, Tasty Hemp Oil Tasty Drops, Tasty Vape Just Peachy and “Alternate Vape Luv-A-Bull)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm484979.htm
Morguetorium, LLC Thackerville, OK (2/4). Reviewed Web site at www.morguejuice.com in January. Misbranded: The claims on the Web site establish that the product which the firm claims contains cannabidiol is an unapproved new drug (Morgue Juice); FDCA502(f)(1)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm484941.htm
PainBomb (2/4). Reviewed Web site at www.PainCBD.com (which redirects to Paindmso.com) and www.PainBomb.com in January. The claims on the Web sites and accompanying literature establish that the products are unapproved drugs (PainBomb+CBD and 35.5% Cannabidiol, which the firm claims contains cannabidiol (CBD), as well as the product PainBomb); FDCA 505
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm484973.htm
Physician Preferred Medical, LLC dba PPM Pharmacy Oklahoma City, OK (1/20). Inspected 2/3-19/15. GMP deviations, adulterated, unapproved new drugs, misbranded: The investigators noted that the firm was not receiving valid prescriptions for individually identified patients for a portion of the drug products it was producing. The firm also failed to have adequate exhaust systems or other systems adequate to control contaminants during production. It does not have, for each batch of drug product purporting to be sterile and/or pyrogen-free, appropriate laboratory determination of satisfactory conformance to final specifications for the drug product, etc. (compounded drug products); 21 CFR 211.167(a), 211.94(c), 211.166(a), 211.67(a), 211.192, 211.113(b), 211.67(a), 211.192
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm484874.htm
Sana Te Newport Beach, CA (2/4). Reviewed Web site at www.sanateoils.com and the Etsy.com marketplace store at www.etsy.com/shop/SanaTePremiumOils in January. The claims on the above Web sites establish that the products are drugs, etc. (Premium Hemp CBD Oil Capsules, Premium Hemp CBD Oil Vile [sic] 5mL,” both of which claim to contain cannabidiol); FDCA 502(f)(1)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm484987.htm