Today FDA posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter.
Accurate Set Inc. Newark, NJ (4/26). Inspected 10/30-11/13/09. QSR deviations, adulterated, misbranded: The firm failed to establish and maintain procedures for implementing corrective and preventive action (CAPA). The firm’s complaint record for the Heat Cure Acrylic did not include information to show whether an investigation was conducted, what caused the material to not set properly, and whether any CAPA was implemented as required by the firm’s written procedure for handling complaints. Quality audits were not conducted at sufficient regular intervals, as prescribed by the firm’s internal audit procedure, etc. (Setacure (Self curing Polymer), Heat and Self Cure Tooth Shade Acrylic Powders, 20-minute Cure Acrylic (Self Cure), Setatone Extra-Hard Crown and Bridge Monomers, Setatone Crown and Bridge Monomers, and Temporary Acrylic for Crown and Bridge); FDCA 501(h), 501(f)(1)(B), 502(o), 515(a), 21 CFR 820.100(a), 820.198(c), (d), & (e), 820.90(a), 820.184, 820.22 (10-NWJ-09)
Braintree Laboratories, Inc. Braintree, MA (5/10) Inspected Holbrook, MA facility 12/3/09-1/22. GMP violations, adulterated: The firm received 21 consumer complaints in 2008-2009 of foreign materials in five finished products (e.g., insects, insect parts, and spiders). It concluded that the foreign material could not be attributed to its manufacturing practices, but did thoroughly investigate whether facility or raw material quality problems were at the root of these complaints. The firm’s 2/10 response states, “We believe that the foreign matter reported [some not verified] in the complaints do not present inherent health hazard.” FDA says the response is inadequate and that it considers contamination of finished drug products with foreign material (e.g., insects) a significant product quality issue. Braintree also concludes in a 3/19 response that contamination with foreign matter could not have occurred while the product was in storage, but it did not provide your rationale for this conclusion, etc. (finished pharmaceuticals); FDCA 501(a)(2)(B), 21 CFR 211.192 (NWE-17-10W)
Heartsine Technologies Inc. Minneapolis, MN (12/10/09). Inspected firm located in Newtown, PA 7/23/09- 8/4/09. Misbranded: The firm failed to keep current records containing information, such as name, address, and telephone number of the distributor, patient, or prescribing physician along with the lot number, batch number, or the serial number of-the device, on each tracked device released for distribution. It also failed to establish a data collection and recording procedure for recording when tracking data is missing and cannot be collected and include the reason why such required data is missing and cannot be collected. The firm failed to conduct an investigation of each event and evaluate the cause of the event, as required, etc. (Class 3 automatic external defibrillator devices); FDCA 502(t)(2), 21 CFR 821.25(b), 821.25(c)(1)&(3), 803.50(b)(3), 803.17 (10-PHI-02)
Medispec, Ltd. Yehud, Israel (3/12). Adulterated, misbranded: The firm is marketing the Radialspec device in the U.S. without marketing clearance or approval. (Radialspec) FDCA 501(f)(1)(B), 502(o), 515(a) (No code)
St. Jude Medical, Inc. Atrial Fibrillation Division Sunnyvale, CA (4/23). Inspected 7/9-29/09. Adulterated, misbranded: The firm is marketing the Epicor LP Cardiac Ablation System and the Epicor UltraCinch LP Ablation Device in the U.S. without marketing clearance or approval. Also, FDA considers claims on the firm’s Web site to be promotion of these devices for the treatment of atrial fibrillation. FDA cleared the Epicor LP Cardiac Ablation System for the intended use of ablation of cardiac tissue during cardiac surgery. FDA also approved an investigational device exemption (IDE) application for the device for the clinical study of a new indication for the treatment of atrial fibrillation. On the firm’s Web site FDA considers the statements: “The Epicor LP system is designed specifically to create the critical Cox Maze III lesions entirely epicardially, which helps mitigate risks associated with other cardiac ablation technologies” and “The Epicor UltraCinch LP Ablation Device ... is designed to safely, effectively and reproducibly create a classic box lesion in a single step” to be promotion of these devices for the treatment of atrial fibrillation.
Also, an Epicor LP Sales Representative Resources CD, an Epicor LP Brochure, and an Epicor LP Spec Sheet make claims outside of their intended use, etc. (Epicor LP Cardiac Ablation System and component devices); FDCA 501(i), 501(f)(1)(B), 502(o) (No code)