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.
Alikay Naturals/Black Onyx World, LLC Fort Myers, FL (3/16). Unapproved new drug, misbranded: FDA laboratory analysis determined that “Bentonite Me Baby” contains lead at levels of 37.5 parts per million or 37.5 micrograms per gram.(Bentonite Me Baby)FDCA 502(f)(1), 502(j)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm491505.htm
Dr NaturalHealing, Inc. Milford, DE (3/10). Misbranded, unapproved new drug: The active ingredient and the claims made for the product, (purged) is a “new drug” within the meaning of section FDCA 321(p) because it is not generally recognized as safe and effective for its labeled uses. The OTC bronchodilator final monograph does not include epinephrine for use as an inhaled bronchodilator in a dry powder dosage form and when using a dry powder inhaler. FDA is concerned about the safety of (purged) and given the available information, it is unclear how much active ingredient would be delivered to a patient when using it even if the conditions of use as set forth in the product labeling are strictly followed. Also, FDA believes that there is a significant risk that patients will either over- or under-dose themselves when using (purged), which could lead to serious and possibly fatal adverse outcomes, etc. (a bronchodilator containing the active ingredient epinephrine); FDCA 505(a), 505(b), (j)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm490546.htm
Essential Pharmacy Compounding Omaha, NE (3/10). Inspected 5/12-5/22. Adulterated: FDA investigators observed that the firm’s drug products intended or expected to be sterile were prepared, packed, or held under insanitary conditions. It failed to demonstrate through appropriate studies that its hoods are able to provide adequate protection of the ISO 5 areas in which sterile products are processed, etc. (sterile drug products); FDCA 501(a)(2)(A)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm491313.htm
Herbal Junction Eugene, OR (3/11). Inspected 5/26-29/15. Adulterated, misbranded: The firm failed to establish a specification for any point, step, or stage in the manufacturing process where control is necessary to ensure the quality of its dietary supplements and that its dietary supplements are packaged and labeled as specified in the master manufacturing record. It also 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. (Herbal Enzyme Elixir Cosmic Think Drink Herbal Supplement, Herbal Enzyme Elixir Exotic Dream Herbal Supplement, Herbal Enzyme Elixir Liver Tea and Justice Herbal Supplement, Herbal Enzyme Elixir Flower Power Herbal Supplement, Herbal Enzyme Elixir Ginger Alchemy Herbal Supplement, Herbal Enzyme Elixir Mate Way Herbal Supplement, Herbal Enzyme Elixir Love Potion #9 Herbal Supplement, Herbal Enzyme Elixir Amazon Nectar Herbal Supplement, Herbal Enzyme Elixir Around the World Herbal Supplement, Herbal Enzyme Elixir Scarlet Ambrosia Herbal Supplement, and Herbal Enzyme Elixir Velvet Vision Herbal Supplement); FDCA 403(y), 21 CFR 111.70(a)-(g), 111.75(c)&(d), 111.205(a), 111.255(a), 111.103
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm491291.htm
Terumo Medical Corporation Somerset, NJ (3/17). Inspected 10/19/15-10/23/15. QSR deviations, adulterated: The firm failed to establish and maintain procedures to control nonconforming product. It also failed to establish and maintain procedures that define the responsibility for review and the authority for the disposition of nonconforming product. Terumo’s response was not adequate. Though its response describes several practices used for ensuring that the solution bottles used in production are acceptable, the firm has not provided information about how nonconforming materials, including bottles that fail the (purged) test will be handled, etc. (destination guiding sheaths for renal, carotid, and peripheral use); FDCA 501(h), 21 CFR 820.90(a), 820.90(b), 820.70(a), 820.30(f)&(g), 820.75(a)&(b)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm491287.htm
Triad Isotopes, Inc. Orlando, FL (3/10). Inspected 1/5-9/15. Violations, adulterated: Investigators found the design and operation of the ISO 5 laminar flow hoods is not adequate to prevent disruption of clean unidirectional airflow during aseptic operations. Operators use non-sterile gloves and non-sterile forearm covers donned in an unclassified area not supplied by HEPA filtered air. Also, there are no magnehelic gauges installed on the (purged) primary ISO 5 laminar hoods to confirm that they are operational, etc. (sterile drug products); FDCA 501(a)(2)(A)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm491181.htm
VitaCare Pharma, LLC South Plainfield, NJ (3/7). Inspection 10/13/15-11/3/15. GMP violations, adulterated: The quality control operations failed to determine whether all components, packaging, and labels conform to specifications. The firm relied on certificates of analysis (COA) from the suppliers of components used in its dietary supplement products to confirm the identity of these components, but failed to qualify the suppliers of components used by establishing the reliability of the supplier’s COA through confirmation of the results of their tests or examinations, etc. (dietary supplements); 21 CFR 111.75(a)(2)(ii)(A)(C), 111.70, 111.260(e), 111.325(b)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm490871.htm
Universal Formulas, LLC Kalamazoo, MI (3/3). Inspected 5/13/15-6/1/15. Reviewed Web sites at www.universalformulas.com and www.mybepure.com. Unapproved new drugs, unadulterated, misbranded. The claims on the Web sites establish that the products are unapproved new drugs, etc. (Quint-Essence Blend, TraciteTM Mineral Formulation, Niacin 100 mg, Natural Vitamin D3, EB-Digestive Aid, Sweet Balance, EssiaCaps, Natural Vitamin E 400 IU, HerpEx, InflamEx, ParasitEX, CandidaEX, Asthma Wellness Protocol, ALS (Lou Gehrig’s Disease) Protocol, Blood Pressure Wellness Protocol, ADD and ADHD Management Protocol, Breast Carcinoma Nutritional Support Protocol, Melanoma Nutritional Support Protocol, and Colon Carcinoma Nutritional Support Protocol); FDCA 505(a), 502(f)(1), 21 CFR 111.70(e), 111.75(c)&(d), 111.205(a), 111.255(a), 111.410(b), 111.465(b), 111.70(f), 403(s)(2)(C)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm490486.htm