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# Latest FDA Warning Letters
- URL: https://www.fdaweb.com/latest-fda-warning-letters-81/
- Published: 2016-09-06T12:00:00.000Z
- Updated: 2026-09-14T21:29:27.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5136711

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

**Central Admixture Pharmacy Services, Inc.** Allentown, PA (8/19). Inspected Allentown, PA facility 6/4-11/14 and from 2/3/15-2/11/15\. Inspected San Diego, CA facility 8/4-8/14\. CGMP deviations, adulterated, unapproved new drug products: FDA investigators noted that drug products compounded in the Allentown and San Diego facilities that were intended or expected to be sterile were prepared, packed, or held under unsanitary conditions, whereby they may have become contaminated with filth or rendered injurious to health. At both facilities, the firm has not thoroughly investigated the failure of a batch or any of its components to meet its specifications whether or not the batch has already been distributed. It also failed to establish an adequate system for cleaning and disinfecting the room and equipment to produce aseptic conditions, etc. (drug products); FDCA 502(f)(1), 501(a)(2)(A)&(B), 21 CFR 211.192, 211.113(b), 211.42(c)(10)(iv)(v), 211.28(a), 211.166(a), 211.167(a)  
[http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm518429.htm](http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm518429.htm?ref=fdaweb.com)

**Healing Noni Co. LLC** Pahoa, HI (8/26). Inspected facility 12/17/15-12/22/15\. Also reviewed Web site at www.healingnoni.com in March and June. GMP violations, adulterated, misbranded: Examples of some of the labeling claims that provide evidence that the firm’s Noni Juice products are intended for use as drugs include: “1-Hexanol – antiseptic,” “Acetic acid – bactericide, fungicide,” and “Asperuloside – antiinflammatory, laxative.” The products are not generally recognized as safe and effective for the claimed uses. (Healing Noni Brand: “Organic Noni Juice 100% Pure noni juice” and Healing Noni Brand: “all natural Goji Juice made with 100% Pure goji juice”); FDCA 505(a), 502(f)(1), 403(s)(2)(B), 403q(5)(F), 403(r)(1)(A), 21 CFR 111.70(d), 101.36  
[http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm518533.htm](http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm518533.htm?ref=fdaweb.com)

**Healing-Scents** Rockford, IL (7/29). Reviewed the firm’s Web site at http://healingscents.com/index.php in June. Unapproved new drugs, misbranded: The claims on the site establish that the products are drugs. For example, the site makes the claim for Cholesterol Regulation Herbs: “These herbs help the body lower high serum cholesterol and to help prevent the deposition of dietary cholesterol on arterial walls.” It also claims for Diabetes Regulation Herbs: “Promotes the body's ability to reduce high blood sugar,” etc. The products are not generally recognized as safe and effective for the claimed uses. (Age Spot Eraser, Eczema and Psoriasis Shampoo, Need Seem Oil, Hypertension Massage Formulas Oil or Lotion, Heart Herbs, Cholesterol Regulation Herbs, Diabetes Regulation Herbs, Prostate Healer Herbs, High Blood Pressure Herbs, Respiratory Ailment Herbs, Stomach/Intestinal Herbs); FDCA 505(a), 502(f)(1)  
[http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm518517.htm](http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm518517.htm?ref=fdaweb.com)

**Jack P. Herick, Inc., dba Glades Drugs** Pahokee, FL (8/9). Inspected 11/23-12/10/15\. Misbranded: FDA received three MedWatch reports, dated 11/12,13,17/15, of adverse events experienced by three patients who were hospitalized after ingesting vitamin D3 supplement capsules produced by the firm. FDA analysis of these samples found that they contained a range of approximately 435,600 to 39,000,000 IU/gram of cholecalciferol per capsule, which far exceeds the label claim (vitamin D3 supplement capsules); FDCA 502(a)  
[http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm518532.htm](http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm518532.htm?ref=fdaweb.com)

**KCE, LLC** Pahoa, HI (8/26). Inspected facility 12/17/15-12/22/15\. GMP deviations, adulterated: 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. It also failed to prepare a batch production record every time it manufactured a batch of dietary supplement. The firm failed to conduct at least one appropriate test or examination to verify the identity of any component that is a dietary ingredient prior to its use, etc. (Healing noni Brand: “Organic Noni-Juice 100% Pure noni juice” and Healing noni Brand: “all natural Goji Juice made with 100% Pure goji juice”); 21 CFR 111.210, 111.255(a), 111.75(a)(1)(i)  
[http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm518758.htm](http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm518758.htm?ref=fdaweb.com)

**La Bella Figura, LLC** Chicago, IL (7/21). Reviewed Web site http://www.labellafigurabeauty.com/ in May. The claims on the site establish that the products are drugs. For example, the site makes the claim for Daily Elements Defense Facial Oil: “\[E\]asily absorbed due to its small molecular structure increasing circulation… rebuild cell structure and support new growth…” The products are not generally recognized as safe for the claimed uses, etc. (Crema Virtuosa Night Cream, Daily Elements Defense Facial Oil, Jardin de Fleurs Skin Revitalizer, and Modern Radiance Concentrate); FDCA 505(a)  
[http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm518518.htm](http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm518518.htm?ref=fdaweb.com)

**Lima & Pergher Industria e Comercio S/A** State of Minas Gerais, Brazil (8/25). Inspected 2/29-3/3\. GMP deviations, adulterated: The firm failed to establish adequate written responsibilities and procedures applicable to the quality control unit. It failed to perform microbiological testing on each lot of finished product. The firm had no stability data to support its expiration date. Also, during the inspection FDA investigators determined that the raw material qualification process was inadequate for the firm’s drug products, etc. (finished pharmaceuticals); FDCA 501(a)(2)(B), 21 CFR 211.22(d), 211.113(a), 211.84(d)&(e), 211.137(a)  
[http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm518694.htm](http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm518694.htm?ref=fdaweb.com)

**Menscience Androceuticals** Miami, FL (7/18). Reviewed Web site at http://www.menscience.com/ in May. The claims on the site establish that the product is a drug. For example, it makes the claim for the Anti-Aging Formula: “GABA Relaxes muscles and bodily tissues by inhibiting and controlling nerve impulses. Because of its unique ability to release muscle tension, it is being used in a variety of ways, from treating nerve disorders and epilepsy to promoting hormone growth and as a dermatological-grade ingredient.” The product is not generally recognized as safe and effective for the claimed uses, etc. (Anti-Aging Formula); FDCA 505(a)  
[http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm518529.htm](http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm518529.htm?ref=fdaweb.com)

**Pan Drugs Limited** Vadodara, India (8/25). Inspected 11/30-12/3/15\. GMP deviations, adulterated: The firm failed to establish an adequate quality control unit with the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging material, labeling, and drug products. The firm’s quality unit allowed the use of adulterated (purged) USP API, dated 5/25-31/15, manufactured at the Pan Drugs Ltd. Nandesari facility. The quality unit approved certificates of analysis for (purged) API, as well as finished products, prior to conducting all quality control and release testing, etc. (finished pharmaceuticals); FDCA 501(a)(2)(B), 21 CFR 211.22(a), 211.56(a), 211.67(a), 211.68(b)  
[http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm518540.htm](http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm518540.htm?ref=fdaweb.com)

**Pegasus Laboratories, Inc.** Pensacola, FL (8/5). Reviewed the firm’s product labeling and Web site at www.prnpharmacal.com. Unapproved new animal drugs, adulterated: FDA has determined that the firm’s products are intended for use in the mitigation, treatment, or prevention of diseases in animals, which makes them drugs. For example, the site and labeling claims that “CAMEO Otic helps control chronic malodorous discharges caused by bacteria and yeast, which is often associated with other secondary symptoms, such as redness, pain, and itching,” etc. (Canine Cameo Otic, Gastromate and CitraVet); FDCA 501(a)(5)  
[http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm518460.htm](http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm518460.htm?ref=fdaweb.com)

**VetraGenics, LLC** Atlanta, GA (8/9). Reviewed Web site at www.vetragenics.com. Unapproved new animal drugs, adulterated: FDA has determined that the products, injectable cell-based, regenerative therapy products for animals, are promoted and sold on the Web site and are intended for use in the mitigation, treatment, or prevention of diseases in animals, which makes them drugs. The products are not generally recognized among experts qualified by scientific training and experience to evaluate the safety and effectiveness of animal drugs, as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling. (VetraRenew, VetraGen, VetraSight, VetraWound, VetraShield and VetraShield/Dry); FDCA 501(a)(5)  
[http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm518593.htm](http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm518593.htm?ref=fdaweb.com)

**Zhejiang Hisoar Pharmaceutical Co., Ltd.** Taizhou City, Zhejiang Province, China (8/11). Inspected 8/10-13/15\. CGMP deviations: FDA investigators discovered a lack of basic laboratory controls to prevent changes to the firm’s electronically-stored data and paper records. When the firm encountered suspect and out-of-specification results, it retested samples until it obtained desirable results. It also failed to investigate, review, or report original results. During the inspection, FDA investigators observed that the laboratory systems lacked access controls to prevent deletions or alterations to raw data, etc. (active pharmaceutical ingredients); FDCA 501(a)(2)(B)  
[http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm518546.htm](http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm518546.htm?ref=fdaweb.com)