# FDA 483 - Cetero Research - December 10, 2010

Source: https://www.keypedia.com/records/483/cetero-research/46ba1687-de3b-4fba-98f8-6d525be911d6

> FDA 483 for Cetero Research on December 10, 2010. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Cetero Research
- Inspection Date: 2010-12-10
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: 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:**

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Company: https://www.keypedia.com/companies/cetero-research/5afece67-6100-427a-995f-1b6e45d77724

Office: https://www.keypedia.com/offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c