Today FDA posted its latest batch of Warning Letters. They can be accessed in Adobe PDF format by clicking on the link following each letter.
Creative Clinical Concepts, Inc. Denver, CO (11/10). Reviewed Web site, http://www.aspirinworks.com. Adulterated, misbranded; Class 3 device has not been approved or cleared for marketing (AspirinWorks test); FDCA 501(f)(1)(B), 502(o), 510(k) (No Code)
Penn Herb Co. Ltd Philadelphia, PA (10/5). Inspected 6/23. Misbranded: Claims made on the company’s Web site establish that the products are drugs because they are intended for use in the cure, mitigation, treatment, or prevention of disease. For example, the product label on Gluo-Ease Plus claims: “Diab-Ease is helpful for hypoglycemia, or low blood sugar.” The product label on Arth-Ease states, “This unique formula contains herbs … to help reduce the pain and inflammation of rheumatism.” The products fail to bear adequate directions for use, etc. (Gluco-ease Plus, Arth-Ease, Prostaid Plus, Soothing Bowel Support, Golden Seal & Myrrh, Colostrum (06-PHI-01)
Primary Care Solutions, Inc. Zephryllis, FL (10/24). Inspected 8/22-29. QSR deviations, adulterated, misbranded: The firm failed to adequately validate several processes. For example, the firm failed to complete validation to assure devices can withstand repeated ethylene oxide sterilization cycles as promoted in the firm’s marketing brochure. Firm also failed to verify or validate corrective and preventive actions to ensure that they do not affect the finished device adversely. For example, in response to four complaints received 3/23-8/17/04 about breaking syringe flanges, Primary Care made a change to Bessell material 2/04 and made a design change to the flange 11/04, but no verification/validation of effectiveness was conducted prior to the changes being implemented. Design control procedures do not include the design of the packaging and labeling, a definition of design verification and validation, a description of how design changes will be documented, or a requirement in the Design and Development Planning section to identify the group or individual responsible for each part of the project and/or the time schedule when project goals are to be completed, etc. (sterile water and saline in bottles and cups, sterile pre-filled inflation syringes used for irrigation and suctioning of medical devices); FDCA 502(t)(2), 21CFR 820.75(a), 820.100(a)(4), 820.198(e)(6), 820.50(a), 820.30(a)&(g)&(j), 820.70(g)(1), 803.17 (FLA-06-01)