Today FDA posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter.
Anulex Technologies, Inc. Minnetonka, MN Inspected 8/23-9/22/10. Clinical investigator violations: The sponsor failed to submit an application to the FDA and obtain approval prior to allowing subjects to participate in an investigation. The sponsor permitted the Xclose device, a significant risk device to be implanted in (purged) of the 750 subjects enrolled in this study prior to submission to FDA and FDA approval of an IDE application. FDA cleared Xclose under 510(k) K062307 for the intended use of soft tissue approximation for procedures such as general and orthopedic surgery. The agency considers the annulus fibrosus repair indication to be investigational and outside the scope of the firm’s 510(k) clearance for Xclose, etc. (clinical study “Randomized Study of Anular Repair with the Xclose Tissue Repair System”); FDCA 520(g), 21 CFR 812.20(a)(1) &(2), 812.40, and 812.42, 812.7(a) and (d), 812.43(c) (No code)
Sanofi Aventis Deutschland GmbH Frankfurt am Main Germany (2/9). Inspected 9/6-10,13-16/10. In 6/2010 the firm failed to identify the organisms recovered from a sterility test for Apidra lot #OF100. The airflow velocity inside critical areas of the aseptic processing operations of Line (purged) was found unacceptable by FDA. The firm failed to ensure that each person engaged in the manufacture, processing, packing, or holding of a drug product has the education, training, and experience, or any combination thereof, to enable that person to perform the assigned functions, etc. (drug products); FDCA 501(a)(2)(B), 21 CFR 211.113(b), 211.42(c), 211.25(a) (WL: 320-11-09)
Sanofi-Aventis US LLC Bridgewater, NJ (1/28). Inspected 4/16-5/13/10. The company failed to review, evaluate, and submit adverse drug experience reports that are both serious and unexpected to FDA within 15 calendar days of initial receipt of the information. The company also failed to include all other postmarketing studies in annual reports. For example, NDA annual reports submitted to FDA for marketed drug products were incomplete and did not include all other postmarketing studies, etc. (drug products); FDCA 505(k), 21 CFR 314.80(c)(1)(i)&(ii), 314.81(b)(2)(viii) (11-NWJ-06)
Toxin Technology, Inc. Sarasota, FL (2/8). Inspected 8/9-10/10.GMP deviations, adulterated: The firm’s Quality Unit failed to assure that materials are appropriately tested and the results are accurately reported. For example, the firm reported passing results after failing results were obtained in several instances. The firm failed to investigate numerous OOS test results and lacked a written procedure for investigating OOS test results. The firm also failed to appropriately qualify analytical equipment used for Bacillus Diarrheal Entertoxin ( BDE) testing, etc. (active pharmaceutical ingredient contract testing laboratory); FDCA 501(a)(2)(B) (FLA-11-17)
Tyco Healthcare Canada Pointe-Claire, Canada (2/14). QSR deviations, adulterated: The firm failed to adequately ensure that when the results of a process cannot be fully verified by subsequent inspection and test that the process shall be validated with a high degree of assurance and approved according to established procedure. The firm has not ensured that an identified corrective action is being implemented by the supplier. Also, the firm failed to establish and maintain adequate procedures that define the responsibility for review and the authority for disposing nonconforming product, which shall include documentation of the justification for use of nonconforming product and the signature of the individual(s) authorizing the use. For example, a non- conforming material report was opened due to insects and foreign malter found in the pouches. The justification for “use as is’ was (purged) inspection during packaging but did not provide justification of using the pouches contaminated with insects and foreign matter for the disposition of “used as is,” etc. (saline and heparin vascular access flush syringes); FDCA 501(h), 21 CFR 820.75(a), 820.100 (a)(5), 820.90(b)(1) (No code)