> ## Content Index > Fetch the complete content index at: https://www.fdaweb.com/llms.txt > Use this file to discover other available public pages before exploring further. # Latest FDA Warning Letters - URL: https://www.fdaweb.com/latest-fda-warning-letters-217/ - Published: 2016-01-19T12:00:00.000Z - Updated: 2026-09-15T02:28:25.000Z - Author: David McFarland - Tags: FDA Policy/General, #legacy-id-D5134479 Today FDA posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. **Alkebulan International Services, LLC** Hampton, VA (1/13). Inspected /6-17/15\. CGMP deviations, adulterated, unapproved new drugs: The therapeutic claims on the firm’s Web site and on the product labeling establish that the products are drugs because they are intended for use in the cure, mitigation, treatment, or prevention of disease. For example, it claims that for Moringa Products: “Clinical studies state that Moringa ... supports the immune system in fighting diseases as simple as the flu and as serious as CANCER.” Also, the firm stated that it was unaware of the quality control requirement and it did not have any written procedures for quality control operations for the dietary supplements it distributes, etc. (Aloe Ferox, Moringa products); FDCA 201(g)(1)(B), 21 CFR 111.65, 111.103 and 111.140(b)(l), 111.453, 111.570, 111.70(d) [http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm481915.htm](http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm481915.htm?ref=fdaweb.com) **Chan Yat Hing Medicine Factory** Kowloon, Hong Kong (12/15/15). Inspected 7/6-8/15\. GMP deviations, adulterated: The firm failed to test finished batches of its drug products for the identity and strength of active ingredients. Also, it failed to calibrate and maintain written records for the scale used to weigh components, including active ingredients, prior to their addition into the manufacturing process, etc. (finished pharmaceuticals); FDCA 501(a)(2)(B), 21 CFR 211.165(a), 211.84(d)(1) and (2), 211.166(a), 211.100(a), 211.22(d), 211.68(a) [http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2015/ucm481851.htm](http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2015/ucm481851.htm?ref=fdaweb.com) **DiamoDent** Anaheim, CA (1/5). Inspected 6/17-22/15\. QSR deviations, adulterated: The design history file for “Cement-On Post for 1) (b)(4) 2) (b)(4)” did not contain or reference any design verification activities to ensure that design output met design input requirements. Also, the firm installed and operated (purged) machines since 2012 to manufacture its devices, but it failed to perform process validation to ensure that the machines are qualified and devices manufactured consistently meet all predetermined specifications, etc. (dental prosthetic permanent and temporary implants and abutments); FDCA 501(h), 21 CFR 820.30(f), 820.75(a), 820.70(i), 820.198(c), 820.30(e) [http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm481946.htm](http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm481946.htm?ref=fdaweb.com) **MasterPharm, LLC** South Richmond Hill, NY (1/8). Inspected 4/22/15-5/6/15\. Adulterated, misbranded: The firm produced sterile stock solutions from non-sterile components and then stored them in stoppered containers which were subsequently punctured multiple times throughout the assigned expiry period of up to 180 days. Also, the firm did not utilize a sporicidal agent to disinfect the ISO 5 work surfaces. The labeling was false or misleading in that the Trimix products are labeled as “Injectable”, but an unopened Trimix product sample was bacterially contaminated, etc. (finished drug products); FDCA 501(a)(2)(A), 502(a) [http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm481129.htm](http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm481129.htm?ref=fdaweb.com) **Montana Compounding Pharmacy P.C. dba Montana Compounding Pharmacy and Wellness Center** Missoula, MT (12/11/15). Inspected 4/28-5/8/15\. CGMP deviations, adulterated, misbranded: Investigators noted that the facility was not adequately designed for sterile drug production. The firm has never performed environmental monitoring in your facility and did not use a sporicidal agent or sterile wipes as part of the disinfection program for the aseptic processing area, etc. (drugs); FDCA 501(a)(2)(A), 502(f)(1), 21 CFR 211.56(a), 211.84(d)(6), 211.42(c)(10)(iv)(v), 211.28(a), 211.113(b), 211.111, 211.167(a)) [http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2015/ucm481963.htm](http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2015/ucm481963.htm?ref=fdaweb.com) **Moringa Nativa** Guaynabo, Puerto Rico (12/18/15). Reviewed Web site at http://yvette67.wix.com/moringa-new?deeplink\_referrer=ess#!body-care/ccov in 11/2015\. Misbranded: The claims on the Web site establish that the products are drugs. For example, for it claims the “Benefits of Moringa: Promotes natural Serum cholesterol; It is an anti-inflammatory; Fights many types of Cancers”, etc. (Moringa Nativa Powder and Pure Moringa Capsules); FDCA 502(f)(1) [http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2015/ucm481125.htm](http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2015/ucm481125.htm?ref=fdaweb.com) **Nutrafill, LLC** Dawson, GA (12/18/15). Inspected 6/1-4/15\. Unapproved new drug, adulterated, misbranded: The firm makes claims on a product label for “Natural Solutions Manganese Plus”: “\[I\]s a powerful anti-inflammatory.” Also, during the inspection the general manager (Mr. Burnett) informed FDA investigators that there are no written procedures for quality control, etc. (The Medicine Man’s Manganese Plus, The Medicine Man’s Ginkgo Biloba, The Medicine Man’s Complete Nutrients for Liver, etc.) FDCA 505(a), 21 CFR 111.70(a)&(b), (c)(1), 111.70(d)&(e), 111.73, 111.260, 111.365(i). [http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2015/ucm481876.htm](http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2015/ucm481876.htm?ref=fdaweb.com) **Nutraloid Labs Inc.** Kingston, NY (1/8). Inspected 6/23, 7/9, 9/10, and 10/7/15\. GMP deviations, adulterated, misbranded: The firm has no written procedures for quality control operations nor does it perform any quality control operations for the products it distributes into interstate commerce. It does not review the quality control practices of its contract manufacturers. Also, it does not have any records related to employee training, etc. (dietary supplements); FDCA 403(y), 403(s)(2)(C), 403(q)(1), 21 CFR 111.103, 111.140(b)(1)(2), 111.16, 111.503, 111.553, 111.453 [http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm481874.htm](http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm481874.htm?ref=fdaweb.com) **Perfect Water and Essentials, LLC, dba Aquagen International** Salt Lake City, UT (12/10/15). Inspected 8/3-6/15\. GMP deviations, adulterated, misbranded: The firm does perform laboratory testing on any component that is a dietary ingredient, including sodium chloride and potassium hydroxide, and FDA has not granted an exemption under 21 CFR 111.75(a)(1)(ii). Also, the firm failed to prepare a master manufacturing record for each batch size of the formulation it manufactured for bulk fluids that are used in some of its dietary supplement products, etc. (supplements); FDCA 403(s)(2), 403(y) 21 CFR 111.75(a)(1)(i), 111.205(a), 111.255(b), 111.153, 101.3(g). [http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2015/ucm481875.htm](http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2015/ucm481875.htm?ref=fdaweb.com)