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# Latest FDA Warning Letters
- URL: https://www.fdaweb.com/latest-fda-warning-letters-76/
- Published: 2016-08-02T12:00:00.000Z
- Updated: 2026-09-14T21:20:19.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5136377

Today FDA posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter.

**American Specialty Pharmacy, Inc.** Plano, TX (6/28). Inspected 12/9-19/14\. GMP deviations, unapproved new drugs, adulterated, misbranded: The firm does not have any FDA approved applications on file for the drug products for which it has not obtained valid prescriptions for individually-identified patients or the domperidone products it produces. It failed to establish and follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile, and that include validation of all aseptic and sterilization processes. Also, the firm failed to establish an adequate system for cleaning and disinfecting the room and equipment to produce aseptic conditions, etc. (drug products including Domperidone); FDCA 501(a)(2)(A)(B), 505(a), 502(f)(1), 21 CFR 211.113(b), 211.42(c)(10)(iv), 211.165(f), 211.166(a), 211.94(c), 211.167(a), 211.42(c)(10)(v)  
[http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm513181.htm](http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm513181.htm?ref=fdaweb.com)

**CellOxess LLC** Princeton, NJ (7/22). Reviewed Web sites at www.celloxess.com and www.fertilix.com. The claims on these Web sites establish that these products are drugs. Also claims made on the firm’s Facebook pages, www.facebook.com/CellOxess and www.facebook.com/fertilix, which includes links to the Web site, www.fertilix.com, where products can be purchased directly, provide additional evidence that the firm’s products are intended for use as drugs. For example, on the Fertilix Facebook page on 6/13/15, the site states, “CellOxess is ...dedicated to disease prevention through the diagnosis and treatment of Chronic Cell Oxidative Stress,” etc. (CellOxess); FDCA 502(f)(l), 505(a)  
[http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm513310.htm](http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm513310.htm?ref=fdaweb.com)

**Hsu’s Ginseng Enterprises, Inc.** Wausau, WI (7/22). Reviewed Web sites at www.hsuginseng.com and www.roottohealth.com (which redirects to www.hsuginseng.com). Also, FDA reviewed the firm’s Facebook Web page in May. Misbranded: The page includes claims about American ginseng, which the firm markets as Cultivated Pearl Medium Deluxe Pack. The claims on its Web sites, promotional material, and Facebook page establish that these products are drugs. For example, on the Web page entitled “Ejia Black Soy Bean Powder” it makes claims such as “Lower cholesterol,” “Help prevent diabetes,” and “Improve anemia,” etc. (Alaska Fish Oil, Cultivated Pearl Medium Deluxe Pack, Ejia Black Soy Bean Powder, Ejia Lappa Tea Powder, Ejia Mangosteen Powder, Hokkaido Dried Seaweed, K BEST Vitamin D, Nattozimes, Spirulina Plus B6 & B12, and White Bird’s Nest, etc.); FDCA 502(f)(1)  
[http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm512780.htm](http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm512780.htm?ref=fdaweb.com)

**New Horizon Nutraceuticals, LLC** Kennett Square, PA (7/22). Inspected 1/26-2/8\. GMP deviations, adulterated, misbranded: During FDA’s inspection, the firm informed the investigator that it does not conduct testing to verify the identity of its dietary ingredients, due to financial strain of third party laboratory testing. The master manufacturing records (MMRs) failed to identify specifications for the points, steps, or stages in the manufacturing process where control is necessary to ensure the quality of the dietary supplements and that the dietary supplements are packaged and labeled as specified in the MMR, etc. (dietary supplements such as Elite Series Premium Whey Vanilla Ice Cream); FDCA 403(y), 21 CFR 111.75(a)(1)(i), 111.205(b)(1), 111.210(d)&(e)&(f)&(h), 111.260, 111.103, 111.27(d), 111.25, 111.553, 111.570, 111.503  
[http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm514057.htm](http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm514057.htm?ref=fdaweb.com)

**Sevani Botanica** Conshohocken, PA (7/19). Reviewed Web site at http://www.sevanibeauty.com/ in May. The claims on the site establish that the products are unapproved new drugs, etc. (Advanced Omega Night Repair Serum, Eye Repair Age Defying Eye Crème, Ageless Eyes Revitalizing Eye Serum, and Hyaluronic Wrinkle Defense); FDCA 505(a)  
[http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm513404.htm](http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm513404.htm?ref=fdaweb.com)

**Sircuit Cosmeceuticals** Glendale, CA (7/19). Reviewed Web site at http://sircuitskin.com/ in May. The claims on the Web site establish that the products are drugs, etc. (Revelation intensive anti-wrinkle eye serum, Eye-Tech anti-wrinkle eye emulsion, Oraia anti-aging intensive regeneration complex, and Suggah + anti-aging lip plump treatment); FDCA 505(a)  
[http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm513961.htm](http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm513961.htm?ref=fdaweb.com)

**TriMed, Inc.** Santa Clarita, CA (6/30). Inspected 3/7-18\. QSR deviations, adulterated: The firm failed to review, evaluate and investigate complaints involving the possible failure of a device, labeling and packaging to meet any of its specifications where necessary. For example, it found that 17 Perimeter Bone Plates, Part #WHV-4, had oversized threaded holes, which could allow the non-locking screws to go through the plate. There was at least one instance where the firm received communication that this occurred in a clinical setting, and it did initiate a complaint file for this event. The failure mode of non-locking screws passing through the hole of bone plates during surgeries has not been documented in the risk analysis for the firm’s Supracondylar Elbow Implant System, etc. (implantable bone fixation systems including plates, screws, nails, and wires intended to treat bone fractures of extremities, and instruments and drills); FDCA 501(h), 21 CFR 820.198(c), 820.30(g), 820.100(a), 820.90(a), 820.80(d), 803.50(a)(1)&(2), 803.17, 806.10  
[http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm514006.htm](http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm514006.htm?ref=fdaweb.com)

**Xiamen Origin Biotech Co., Ltd.** Fujian, China (7/19). Inspected 1/18-20\. CGMP deviations, adulterated: The firm had no written procedures for supplier qualification, relabeling operations, sampling, product release, document retention, or training. It was unable to provide the FDA investigator records for relabeling operations from before 9/2014\. The firm fabricated the name of an employee, and used that name as the false signatory authority on the certificates of analysis sent to customers. During the inspection, an employee told the FDA investigator that there were no drugs on site, yet the investigator observed a room adjacent to the conference room that was being used as a warehouse for relabeled drugs, etc. (active pharmaceutical ingredients); FDCA 501(a)(2)(B)  
[http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm512814.htm](http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm512814.htm?ref=fdaweb.com)