Warning letters.

The following are recent FDA warning letters to clinical investigators, IRBs, sponsor/monitors, CROs and testing labs issued in January 2006. Each letter is $7 plus retrieval. Please order by RECORD-RETRIEVE Number (e.g., 12338W, 12399W, etc.). Copies of responses to the letter, along with any 483s and EIRs, are available from RECORD-RETRIEVE: [phone], or [e-mail].

ITT Research Institute, Chicago, Dec.5 (CDER)

Between Jan. 3-7, 2005, FDA inspectors James Plucinski and Charles Snipes, Ph.D., inspected several, unnamed, nonclinical laboratory studies conducted by the firm and found several violations of the GLP regulations.

Violations included failure to assure that test articles or mixtures were appropriately tested; failure to include all circumstances that may have affected the quality or integrity of the final study reports; failure to indicate changes in automated data entries; and failure to have an approved, written protocol for each study.

Lastly, the firm failed to conduct the studies in accordance with the protocol in that the study required the consent of the study director or pathologist prior to sacrificing moribund animals. Doc. 13685W

David D. Dore, M.D., Celebration Orthopedic & Sports Medicine Institute, Celebration, FL, Dec. 21 (CDRH)

FDA inspected Dore's clinical site Aug. 22-Sept. 2, 2005, and found problems in the conduct of his two, unnamed investigational device trials.

According to the warning letter, Dore did not obtain IRB approval to continue the study until Jan. 9, 2001, yet he enrolled and/or performed study surgery on at least five subjects during the lapse.

The agency acknowledged receipt of Dore's response date Sept. 22, but found the response inadequate because he had not addressed the issues surrounding the above examples and no CAPA were planned. Doc. 13690W