FDA Webview

Constantine, Niel T. University of Maryland School of Medicine Baltimore, MD (5/26). Inspected 1/25-2/4/05. Clinical investigator violations: Investigator enrolled five of 98 high-risk subjects reviewed who did not meet the age requirements. There was no documentation that the investigator was present for or reviewed records of the protocol-required test procedures of the device at the IHV (purged) or EJC locations. Investigator changed the finger-stick procedure and the sample shipping requirement, but never sought or received IRB approval to deviate from the protocol. Investigator also failed to prepare and submit a complete and accurate final report, etc. FDA issued the investigator a Warning Letter 11/17/04 for a different study citing such violations as the failure to obtain informed consent and the failure to maintain disposition of the devices. (device study); 21CFR 812.100, 812.110(b), 812.140(a)(3), 812.150(a)(4-6) (CBER-05-016)

http://www.fda.gov/foi/warning_letters/g5352d.pdf

Hostoffer, Robert W. Allergy and Immunology Associates South Euclid, OH (6/6). Inspected 2/9-3/2/05. Investigator violations: Of the five subjects enrolled in the study, four did not meet the eligibility criteria set forth in the protocol. Investigator failed to report a serious adverse event to the sponsor and the IRB in a timely manner. Hostoffer obtained informed consent/assent from subjects or their legally authorized representative using an incorrect consent form that did not accurately describe the study procedures and/or an outdated consent form. He did not maintain adequate records for the disposition of the study drug. For example, the amount of study drug received at home by all subjects could not be accurately determined, etc. (drug study); 21CFR 312.60, 312.62(a), 50 (CBER-05-020)

http://www.fda.gov/foi/warning_letters/g5355d.pdf

Medtronic Emergency Response System Redmond, WA (6/9). Investigated 2/23, 3/2-4, 7, 9-11, 14-18, 21-25, 28, and 31/05. QSR deviations, adulterated: Company failed to verify or validate a corrective and preventive action to ensure that the action is effective and does not adversely affect the finished device. Medtronic also failed to investigate the cause of nonconformities relating to product, processes, and the quality system, etc. (Lifepak 12 defibrillator); FDCA 501(h), 21CFR 820.100(a)(3)(4), 820.100(a)(1)(2) (SEA-05-23)

http://www.fda.gov/foi/warning_letters/g5357d.pdf

Millenium Dental Technologies, Inc. Cerritos, CA (6/7). Inspected 3/15-4/12. QSR deviations, adulterated: Not all complaints received by the company have been reviewed and evaluated to determine whether an investigation is necessary. Company has complaint and returned merchandise data that lack documentation of any investigation. The quality audit procedure is incomplete and no acceptance activities have been documented, etc. (devices); FDCA 501(h), 21CFR 820.198(a), 820.100(a)(1), 820.100(b), 820.22, 820.50, 820.70(i) (W/L 16-05)

http://www.fda.gov/foi/warning_letters/g5356d.pdf

Puronyx, Inc. Vista, CA (6/10). Firm is marketing Soothies Gel Pad in the U.S. for pregnant or breastfeeding women without obtaining marketing clearance or approval. (Soothies Gel Pads); FDCA 501(f)(1)(b), 510(k) (No Code)

http://www.fda.gov/foi/warning_letters/g5358d.pdf