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.
Hartley Medical Center Pharmacy, Inc. Long Beach, CA (4/21). Inspected 6/29-7/8/15. CGMP violations, unapproved new drug products, adulterated, misbranded: 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 its practices for producing sterile drug products. For example, investigators noted that the firm produced sterile (purged) from non-sterile components and then stored them in (purged) containers, which were subsequently punctured multiple times throughout the assigned expiry period of up to (purged) days. Also, the firm did not use a sporicidal agent or sterile wipes, and used non-sterile sanitizers as part of its disinfection program for the aseptic processing areas, etc. (compounded drugs); FDCA 501(a)(2)(A)&(B), 502(f)(1), 505(a), 21CFR 211.42(c)(10)(v), 211.167(a), 211.28(a), 211.113(b), 211.42(c)(10)(iv)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm498592.htm
Macular Health, LLC Gardendale, AL (4/28). Reviewed Web site at www.macularhealth.com in March. Misbranded: The firm’s products are not generally recognized as safe and effective for the referenced uses and, therefore, the products are “new drugs.” Labels fail to bear adequate directions for use, etc. (Visual Advantage Dry Eye Formula, Antioxidant Only Genetic Formula, Zinc Only Genetic Formula, and Low Dose Zinc Genetic Formula, Visual Advantage AREDS II Formula, MacuStrip, Visual Advantage Premier Formula, Blephadex Eyelid Wipes and Blephadex Eyelid Foam); FDCA 502(f)(1)&(2)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm498954.htm
PharmaLogic Holdings Corp. Boca Raton, FL (4/29). CGMP violations, adulterated, misbranded: This letter discusses violations identified during the time you were registered as an outsourcing facility. The investigators observed serious deficiencies in your practices for producing sterile drug products. For example, (purged) is used to make the disinfectants used in the ISO 7 and ISO 8 areas, and no sporicidal agents are used to clean either of these rooms. Also, no disinfectants or sporicidal agents are used in cleaning the (purged) ISO 5 hoods used to make sterile drug products and the (purged) pass-through boxes used to bring supplies into the ISO 7 cleanroom. FDA investigators noted that some of the facility’s drug products do not include the statement “This is a compounded drug” on the label, and none of the facility’s drug products include the statement “Office Use Only” and the date the drug was compounded on the label, etc. (compounded drugs); FDCA 501 (a)(2)(A)(B), 502(f)(1), 21 CFR 211.42 (c)(10)(iv)(v), 211.113(b), 211.84(a)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm499400.htm
Riddhi USA Inc. Ronkonkoma, NY (4/27). Inspected 12/22/15-1/5/15. CGMP deviations, adulterated: The firm has not established product specifications for your Prenatal Formula Tablets, Neuroxygen Capsules, Formula for Men Capsules, and Mulberry Leaf Capsules. It also failed to conduct at least one appropriate test or examination to verify the identity of any component that is a dietary ingredient. Also, the firm failed to include certain required elements on your written master manufacturing records for Prenatal Formula Tablets, Mulberry Leaf Capsules, Neuroxygen Capsules, and Formula For Men Capsules, etc. (dietary supplements); 21 CFR 111.210, 111.65, 111.75(c), 111.75(a)(1)(i), 111.70(b), 111.95(b)(1), 111.103, 111.255(b), 111.260(c)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm498992.htm
Service First Pharmacies, Inc., dba Madison Drugs Huntsville, AL (4/27). Inspected 8/3, 8/4, and 8/15/15. The investigator noted that the firm was not receiving valid prescriptions for individually-identified patients for a portion of the drug products it was producing. Misbranded: Labeling fails to bear adequate directions for use. (drugs); FDCA 502(f)(1), 501(a)(2)(B)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm499394.htm
Summit Beverage Group, LLC Marion, VA (5/2). Inspected 5/4-8 and 15/15. CGMP deviations, adulterated: This letter should not be interpreted to mean that FDA agrees with the characterization of its products as dietary supplements. The labels revealed that the products are represented for use as conventional foods. The product labels bear “Supplement Facts” panels, but the label contains the statement “Function: Alternative Energy ... you’ve never tasted an energy drink this refreshing and delicious.” This statement implies that these products are used as beverages, i.e., for taste and refreshment. The firm failed to take appropriate steps when dietary supplements did not conform to established specifications. It also failed to establish component specifications that are necessary to ensure that specifications for the purity, strength, and composition of the dietary supplements manufactured using the components are met, etc. (Urban Detox Pomegranate Cherry, Goji Berry, and Prickly Pear and Alternative Energy Strawberry Guava, Tropical Citrus, and Acai Grape, etc.); FDCA 402(g)(1), 21 CFR 111.77(a), 111.70, 11.255(b), 111.260
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm498962.htm