FDA 483 - Cetero Research - December 10, 2010

This FDA Form 483 was issued to Dr. Chinna Pamidi, President of Cetero Research, a bioanalytical laboratory located at 10550 Rockley Road, Suite 150, Houston, TX 77099. The inspection occurred from December 6-10, 2010.

The inspection revealed several observations related to studies (b)(4) and (b)(4) concerning the analysis of plasma samples for (b)(4) and (b)(4) concentrations.

Key observations include: 1. **Failure to document "prep" run procedures:** Cetero-Houston failed to identify and document procedures for "prep" run injections, a repeat observation from a May 7, 2010, FDA-483. Analysts did not follow written procedures or document actions during these "prep" runs, which varied in the number of samples and were conducted multiple times without explanation or justification. 2. **Falsification of records:** Records for the extraction of subject samples for (b)(4) and (b)(4) concentration determination were found to be falsified, also a repeat observation from the May 7, 2010, FDA-483. Examples cited include analytical Run 5 and (b)(4), and analytical Run 4 in Study (b)(4). 3. **Lack of stability demonstration:**