FDA 483 - Cetero Research - May 07, 2010

On May 3-7, 2010, the FDA inspected Cetero Research, a bioanalytical laboratory located at 10550 Rockley Rd., Suite 150, Houston, TX 77099. The inspection, addressed to President Chinna Pamidi Ph.D., revealed four observations, with the first two pertaining to Cetero's internal investigation of complaint allegations reported to FDA in June 2009.

Observation 1 noted falsified source records for subject sample extraction in numerous studies. Electronic card key entry times indicated laboratory technicians were not present at the facility during documented sample extraction times in at least 1900 instances between April 2005 and June 30, 2009, affecting multiple studies and sponsors.

Observation 2 detailed a failure to document procedures and identity for "prep" run injections. Over (b)(4) "prep" runs were identified from April 2005 to June 2009, lacking written procedures for selection, evaluation, and reporting. The actual identity of samples in the "prep" folder was not confirmed, and "prep" runs were not recorded in instrument log books, despite the firm's claim that reviewing these runs could address allegations of "fixing" results.

Observation 3 focused on Study (b)(4) and related bioanalytical method validation projects AP LC/MS/MS 30