Cetero Research
Form 483 issued December 10, 2010 · Houston, Texas
- Inspection
- Dec 6 – Dec 10, 2010
- Investigators
- Albert Peacock· John Kadavil· Martin K. Yau
- Observations
- 6
- Pages
- 2
- FEI number
- 1000117586
In short: On December 10, 2010, FDA issued a Form 483 with 6 observations to Cetero Research in Houston, Texas (FEI 1000117586) after an inspection that ran Dec 6 – Dec 10, 2010. The investigators were Albert Peacock, John Kadavil, Martin K. Yau, Sam H. Haidar and Xikui Chen. The most-cited regulation is 21 CFR 320.29 (analytical methods for an in vivo bioavailability or bioequivalence study).
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Failure to identify and document procedures for "prep" run injections as described in the Form FDA-483…
- 02
Review of the records for the extraction of subject samples for the determination of (b)(4) and…
- 03
Stability was not demonstrated under the same conditions as…
- 04
Documentation for the re-injections of analytical…
This inspection in context
Albert Peacock
2 documents · 2010–2011
Cites 320.29 (analytical methods for an in vivo bioavailability or bioequivalence study) more than any other section. Most of their documents are for sites in Texas.
The firmCetero Research history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 320.29
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Cetero Research?
FDA listed 6 observations on this Form 483. The most-cited regulation is 21 CFR 320.29 (analytical methods for an in vivo bioavailability or bioequivalence study). The opening words of each observation are shown on this page.
Who inspected Cetero Research?
Albert Peacock, John Kadavil, Martin K. Yau, Sam H. Haidar and Xikui Chen are named on this Form 483, for the inspection of Dec 6 – Dec 10, 2010. Each investigator has a profile showing what they cite most.
When was Cetero Research inspected by FDA?
The inspection ran Dec 6 – Dec 10, 2010, and the Form 483 is dated December 10, 2010.
How do I get the full Form 483 for Cetero Research?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.