Warning letters.

The following are recent FDA warning letters to clinical investigators, IRBs, sponsor/monitors, CROs and testing labs issued in April 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].

Dennis Devinney, D.O., Tyler, TX, April 21 (CDRH).

An FDA investigation conducted at Devinney's clinical site Jan. 9-23 revealed serious violations of IDE and protection of human subjects regulations.

The deviations noted included failure to obtain proper informed consent before any study-related procedures. FDA said the investigation revealed that, for nine of the 19 subjects enrolled in the study, proper informed consent was not obtained.

Moreover, two of the subjects had study-related procedures before being consented; and, seven of the subjects were consented with a version of the consent document that was not IRB-approved.

Devinney also was cited for failure to ensure the investigation was conducted in accordance with the signed agreement, the investigational plan and applicable FDA regulations.

For example, Devinney implanted three subjects with unapproved devices that were not part of the investigational plan; two subjects who did not meet the inclusion/exclusion criteria were enrolled; and, there was no documentation indicating the sponsor or the IRB approved of these deviations.

According to the warning letter, Devinney also failed to conduct follow-up procedures and exams in accordance with the investigational plan; failed to submit unanticipated adverse device effect reports to the reviewing IRB; and failed to maintain accurate, complete and current records of each subject's case history and exposure to the device.

FDA said 11 of the subjects enrolled were not being followed for various reasons; three subjects withdrew; four were lost to follow-up; and an additional four did not receive any follow-up.

"This lack of follow-up is a safety concern since these subjects were implanted with an investigational device," the agency emphasized. Doc. 13781W

HemaCare Corp., Woodland Hills, CA, April 27 (Los Angeles).

During a March inspection of HemaCare, FDA investigators documented several deviations from the FD & C Act.

Violations included failure to notify consignees of blood components made from prior collections within 72 hours from a donor who subsequently tested HIV positive; failure to maintain concurrent documentation of each significant step in the collection; and failure to have written and approved procedures in place.

Specifically, FDA said there was no written or approved procedures describing a standard method of entering donor demographics into HemaCare's databases, and/or describing what routine reports were to be run and how to review the reports for maintaining the Tracking Card Database.

Furthermore, the agency noted that HemaCare neglected to maintain written SOPs for all steps in the collection, processing, storage and distribution of blood and blood components; and it failed to perform a thorough investigation of unexplained discrepancies. Doc. 13779W