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.
Chemolee Lab Corp. Irving, TX (2/23). Inspected 1/12/15-2/13/15. GMP deviations, adulterated, misbranded, unapproved new drugs: The firm failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed, and failed to extend the investigation to other batches that may have been associated with the specific failure. This was a repeat violation from the 9/2011 inspection. Acne Control Spot Treatment lots manufactured in 8-9/2013 were rejected because they failed established microbial specifications for total microbial count, but the quality control unit did not adequately investigate these specification failures, etc. (Restless Legs Cream, Shingles Anti-Itch Recovery Cream, Shingles Recovery Cream Anti-Itch Formula, Lung Cream Herbal Formula, Anti-Inflammatory & Pain Relief Cream, Diabetic Foot Cream Anti-Itch Formula, Acne Control Spot Treatment); FDCA 502(f)(1), 211 .192, 21 CFR 211.100(a), 211.160(b)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm488759.htm
Herbal Energetics/In Joy Organics Northfield, NH (2/25) Inspected 9/23-10/16/15. GMP deviations, unapproved new drugs, adulterated dietary supplements: The products are not generally recognized as safe and effective for their referenced uses The firm did not establish written procedures for its quality control operations for conducting material review. The “X Out-Rays” product label fails to bear nutrition information in the form of a “Supplement Facts” panel. The firm failed to establish specifications for any point, step, or stage in the manufacturing process where control is necessary to ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing record, etc. (X Out-Rays, Stop It Cold, SOS Flower Essence, Decongest, Smoke No More, Goodbye Pain, Cough Release for Babies and Small Children, Cough Release, Childrens Stop It…Cold Flu, Viral Resolve, and Flu the Coop); FDCA 505(a), 403(q)(5)(F), 403(s)(2)(B)&(C), 403(u), 403(i)(2), 21 CFR 111.70(a), 111.70(b)(3), 111.70(e), 111.103, 111.260
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm488394.htm
HoneyCombs Industries, LLC. Montrose, CO (2/24). Inspected 7/7-10/2015. Reviewed Web site at www.honeycombsindustries.com. Unapproved new drugs, misbranded. (Cough Syrup, Formula C&F (Cold & Flu) Liquid Alcohol Free Extract, Month 6 (Parasites & Microbes), and Formula P (Parasites, Children & Elderly) Liquid Alcohol Free Extract); FDCA 505(a), 502(f)(1), 21 CFR 111.70, 111.75(a)(2)(ii)(C), 111.210(h)(3), 111.260, 111.255, 111.103, 111.25(c), 111.83(a)&(b)(1), 111.415(f)(1)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm488547.htm
Jamaica Hospital Institutional Review Board Jamaica Hospital Medical Center Jamaica, NY (2/24). Inspected 8/13-20/15. The IRB failed to prepare and maintain adequate documentation of IRB activities, including minutes of IRB meetings and a list of IRB members. For IRB meetings held between 1/7/13 and 7/6/15, vote counts were not recorded in the meeting minutes consistently, but instead the minutes indicate, “The committee acknowledged and approved the submission,” etc. (IRB); 21 CFR 56.115(a)(2), 56.115(a)(5)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm488140.htm
Raphah, Inc. North Brunswick, NJ (2/26). Inspected 9/17-9/30/15. GMP deviations, adulterated: The firm failed to establish required specifications for points, steps, or stages in the manufacturing process where control is necessary to ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing record. The firm also failed to collect representative samples of a subset of finished batches of dietary supplements that it manufactured before releasing for distribution to verify that the batch meets established product specifications, etc. (dietary supplements); FDCA 402(g)(1), 21 CFR 111.70(a)&(b)&(c)&(d)&(g), 111.80(c), 111.123(b)(2), 111.205(a), 111.255(b), 111.260, 111.75(a)(1)(i), 111.103, 111.455(c), 111.453, 111.465(a)&(b)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm488392.htm
Repro-Med Systems, Inc. dba RMS Medical Products Chester, NY (2/26). Inspected 6/3-23/15. QSR deviations, unapproved Class 3 devices, adulterated, misbranded: The firm modified the Freedom 60 Syringe Infusion Pump, cleared under K933652, in a manner that could significantly affect safety and effectiveness when it: Changed the pressure specification range from 13 psi maximum to 15 psi maximum; changed the flow rate specification range from 1 – 500 ml/hr. to 0.5 - 2400 ml/hr.; and developed and marketed a different version of the Freedom 60 Syringe Infusion Pump (i.e., Freedom Edge Infusion pump) that uses a different syringe volume, pumping mechanism and mode of operation. The firm is promoting the device for infusing prescribed liquid medicines including Immunoglobulin G (IgG,) antibiotics, Desferal, pain medications, chemotherapeutics and cardiac medications when it is only cleared for IV infusion and not infusion of specific medications or blood or blood products, like IgG, etc. (Freedom 60 Syringe Infusion Pump, Freedom Edge Syringe Infusion Pump and accessories); FDCA 501(f)(1)(B), 502(o), 502(t)(2), 510(k), 501(h), 21 CFR 820.30(f), 820.30(b), 820.72(a), 820.90(b)(2), 820.100(a), 820.80(a), 803.17
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm488301.htm
Sharim Distributing Co., Inc. Independence, MO (2/11). Inspected 6/23-30/15. Unapproved new drugs, misbranded: FDA confirmed through laboratory analysis that (purged) contain the following undeclared phosphodiesterase type-5 (PDE-5) inhibitors: sildenafil and dithiodesmethylcarbodenafil. All three of the products are intended to affect the structure or function of the body and, thus, are drugs, etc. (drugs); FDCA 502(f)(1), 502(a)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm488185.htm
VitaSea Products Int’l, Inc. dba Wachters Organic Sea Products Daly City, CA (2/25). Reviewed Web site at www.wachters.com in 7/2015 and 12/2015. Inspected facility at 550 Sylvan St., Daly City, CA from 4/2/15-4/17/15. CGMP deviations, unapproved new drugs, misbranded: For example, On the NEWS FLASH section of the Web site’s main page the firm claims: “Seaweed Kills cancer cells and HIV virus” (seaweed is an ingredient in some of the firm’s products, including No. 19 N-er-G). Also, the firm failed to prepare and follow a written master manufacturing record for each unique formulation of dietary supplement that it manufactures, and for each batch size, to ensure uniformity in the finished batch from batch to batch, etc. (No. 54 Vitamin C and Quercetin, No. 2 Aqua Terra, No. 3 Sea Green Drink, No. 11 Sea Klenz with Phytoenzymes, WMH Migraine-B-Gone, WTCB T Cell Balancer, and No. 19 N-er-G); FDCA 505(a), 502(f)(1), 402(g)(1), 403(i)(2), 403(s)(2)(C), 403(q)(1)(A) 21 CFR 111.70(a)&(b), 111.70(c)(1), 111.70(e)&(g), 111.103, 111.205(a), 111.255(c), 111.260(j) and (l), 111.365
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm489158.htm