Latest FDA Warning Letters
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter.
NutriResearch, Inc. Kent, WA (11/15): FDA reviewed the firm’s Web site and determined that claims on its product labels and pamphlets establish that the dietary supplements are being marketed as drugs because they are intended for use in the cure, mitigation, treatment, or prevention of disease. Products cited include Chaga, Eye Health, Hepatocel Plus, Reishi, Coriolus, Horny Goat Weed, GlucoResistance, and Healthy Vision.
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm529991.htm
Pine Pharmaceuticals Tonawanda, NY 11/7): FDA inspected the outsourcing facility 10/2015 and determined that the firm failed to meet the conditions necessary for drugs produced by an outsourcing facility to qualify for exemptions from certain requirements under the Food Drug and Cosmetic Act. The agency determined that some of the facility’s drug products do not include a list of the inactive ingredients or the proportion of each ingredient. The firm also failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications. Additionally, the firm does not have an appropriate laboratory determination of satisfactory conformance to final specifications for each drug product.
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm529217.htm
Physician Therapeutics Los Angeles, CA (10/6): FDA reviewed the firm’s listing information provided for several drug products and determined that information is missing. Specifically, the firm failed to update drug listing files to reflect discontinuance of certain drug products.
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm529480.htm
Srikem Laboratories Ltd. Navi Mumbai, India (11/8): FDA inspected the firm 12/2015 and documented significant GMP deviations for active pharmaceutical ingredients. For example, the firm failed to have laboratory control records that include complete data derived from all laboratory tests conducted to ensure compliance with established specifications and standards. Also, the agency investigator observed inconsistently-dated laboratory records. Additionally, the firm’s quality system does not adequately ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of the drugs you manufacture. FDA strongly recommend that it retain a qualified consultant to assist in its remediation.
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm529237.htm
Wockhardt Ltd. Mumbai, Maharashtra, India (11/16): FDA investigators inspected the firm’s CP Pharmaceuticals drug operations in Wrexham, UK 10/2015 and documented significant GMP violations. For example, the firm failed to 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. Additionally, the firm’s environmental monitoring program did not sufficiently cover personnel in its ISO-5 area during set-up, filling, and other activities in the aseptic processing rooms.
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm529931.htm