Today FDA posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter.
Heritage Pharmaceuticals, Inc. Eatontown, NJ (11/5). Inspected 5/12-27. Violations: The firm failed to report each adverse drug experience (ADE) not reported under 21 CFR 314.80(c)(1)(i) at quarterly intervals for three years from the date of approval of the application, and then at annual intervals. Also, the firm does not have adequate written procedures to ensure that adverse drug experiences are correctly assessed and reported to FDA in accordance with postmarketing regulations. The SOPs fail to ensure that: (1) all ADE information obtained from all sources is promptly conveyed to the appropriate Heritage personnel and reviewed, (2) all ADEs are evaluated against the U.S. package insert for seriousness and expectedness, (3) all ADEs are reported accurately from source documentation to the FDA, (4) all ADEs that are the subject of 15-day alert reports are promptly investigated and all attempts to obtain additional information about the adverse experiences are recorded, and (5) a Form FDA 3500A for each ADE not reported as a 15-day alert report etc. (drugs); 21 CFR 314.80(c)(1)(i)&(2)(i), 314.98(a), 314.80(b)
Life Support Development Ltd. Columbus, OH (9/17). Inspected 12/16,17, 22 and 30/2014. CGMP violations, unapproved new drug: FDA has determined that the Life Support Hangover Relief product is being promoted for conditions that cause the product to be a drug. For example, on the Web site the company claims: “Life Support can protect the liver and brain from damage …” Also, an employee stated that the firm did not have specifications for incoming components. Though the firm informed the FDA investigator that it did not have a master manufacturing record (MMR), there is evidence to suggest that it maintains documents that contain elements of an MMR, but do not contain all the required elements such as a) the strength, concentration, weight or measure of each dietary ingredient for each batch size; b) an accurate statement of the weight or measure of each component to be used, or c) a statement of theoretical yield of a manufactured dietary supplement expected at each point, step, or stage of the manufacturing process, etc. (Life Support Hangover Relief); FDCA 505(a), 21 CFR 111.70, 111.210, 111.353, 111.103, 111.83(a), 111.255(b), 111.260, 111.225(a), 111.553, 111.403, 111.453, 111.8, 111.15(b)(1)