Today FDA posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter.
Griffin, John MD Cardiovascular Associates, Ltd. Virginia Beach, VA (3/14). Investigated 5/12 and 7/15/10. Clinical investigation violations: The investigator failed to personally conduct or supervise the clinical investigation in that he did not adequately supervise the research nurse to whom he delegated tasks. The research nurse improperly completed or signed the investigator’s name on certain documents. Two subjects were enrolled in the clinical investigation even though they did not satisfy the inclusion criterion. (clinical study); 21 CFR 312.60 (11-HFD-45-02-01)
Health Robotics Srl Bolzano, Italy (3/14). Inspected 11/8-12/10. QSR deviations, adulterated: The firm failed to establish and maintain adequate procedures for validating device design. The Improvement/Corrective and Preventive Actions procedure (D ZM 03.01) does not describe the frequency of collecting data and trending information to ensure the corrective action is initiated. There is also no documentation to ensure quality data source information is being analyzed, etc. (pharmacy compounding systems - the CytoCare system and i.v.STATION system); FDCA 501(h), 21 CFR 820.30(f)&(g), 820.100(a), 820.198(a), 820.22 (No code)
Iso-Tex Diagnostics, Inc. Friendswood, TX (12/3/10). Inspected 5/4/10-6/2/10. QSR deviations: The firm has not thoroughly investigated the failure of a batch or any of its components to meet its specifications whether or not the batch has already been distributed. The firm failed to thoroughly investigate positive sterility test results for both canisters in the sterile injectable drug product, Glofil I-125. The firm also failed to validated the filter used in the sterilization of its drug products, etc. (finished pharmaceuticals); FDCA 501(a)(2)(B), 21 C.F.R. 211.192, 211.113(b), 211.42(c)(10)(i), 211.46(c) (2011-DAL-WL-03)
Nanotherapeutics, Inc. Alachua, FL (2/22). Inspected 8/30/10-9/7/10. Adulterated, misbranded: Unapproved device, QSR deviations, adulterated, misbranded: The firm failed to review and evaluate the process and perform revalidation, where appropriate, when changes or process deviations occur and to document these activities. Neither the current Design Control SOP nor the Change Control System SOP addresses design change. The continuing nonconformances observed during the 100% inspection are not fed back into the CAPA system to determine if additional actions are required in-house or at the contract packaging facility, etc. (Origen DBM/NanoFUSE DBM with Bioactive Glass); FDCA 501(f)(1)(B), 21 CFR 820.75(c), 820.30(i), 820.100(a)(4), 820.198(a), 820.50(a)(3), 820.80(d), 820.30(j), 820.22, 820.20(c) (FLA-11-19)
Non-Invasive Monitoring Systems, Inc. (NiMS) Miami, FL (3/18). Inspected 3/24-25/10. Adulterated: FDA reviewed the firm’s Web site at www.nims-inc.com for the Exer-Rest and has determined that it promotes the Exer-Rest for uses for which the firm has not obtained marketing approval or clearance. The product is classified as a therapeutic vibrator, a Class 1 exempt device, when it is intended for relaxing muscles and relieving minor aches and pains. The “Study Support” section of the firm’s Web site indicates that the device may be used during CPR, as “cardioprotective preconditioning,” for brain damage reduction in ischemic strokes, for asphyxia, for enhancing brachial endothelial function, for cardiovascular disease, for asthma, and for fibromyalgia, etc. (Exer-Rest); FDCA 501(f)(1)(B), 515(a), 520(g), 510(k) (EC100318)
R82 A/S Gedved, Denmark (3/14). Inspected 10/4-7/10. QSR deviations, adulterated, misbranded: The firm failed to establish and maintain adequate procedures for rework, to include re-testing and reevaluation of the nonconforming product after rework, to ensure that the product meets its current approved specification. The firm also failed to establish and maintain adequate procedures for receiving, reviewing, and evaluating complaints by a formally designated unit to include determining whether the complaint represents an event which is required to be reported to FDA, etc. (pediatric mobile standing frames, wheel chairs, gate trainers, and toilet/bath accessories); FDCA 501(h), 502(t)(2), 21 CFR 820.90(b)(2), 820.100(a)(4), 820.198(a)(3)&(c), 820.30(e), 820.120, 803.17 (No code)
Tytan Medical, Corp. Shanghai, China (2/18). Inspected 10/25-28/10. QSR deviations, adulterated: According to the General Manager and Production Manager there is no design control process established for the manual sphygmomanometers manufactured since 2004 because there were no design control procedures defined until 5/2006. The firm also failed to adequately establish and maintain procedures for corrective and preventative action, etc. (Class 1 stethoscopes and Class 2 manual sphygmomanometers); FDCA 501(h), 21 CFR 820.30(a), 820.100(a), 820.198(a) (No code)