Cetero Research
Form 483 issued May 7, 2010 · Houston, Texas
- Inspection
- May 3 – May 7, 2010
- Investigators
- Carol M. Rivera-Lopez· Jacqueline A. Oshaughnessy· Patrick Stone
- Observations
- 4
- Pages
- 2
- FEI number
- 1000117586
In short: On May 7, 2010, FDA issued a Form 483 with 4 observations to Cetero Research in Houston, Texas (FEI 1000117586) after an inspection that ran May 3 – May 7, 2010. The investigators were Carol M. Rivera-Lopez, Jacqueline A. Oshaughnessy and Patrick Stone.
What FDA observed
Preview: the opening words of each observation- 01
Records for the extraction ofsubject samples in…
- 02
Electronic records of chromatography acquisition for subject sample analysis include a "prep" folder in addition to…
- 03
Observation 3: scanned text, readable in the full document.
- 04
Incomplete documentation for the reinjection of Ron 35 for incurred sample reproducibility in that the reinjectionreport…
This inspection in context
Questions about this 483
What did FDA find at Cetero Research?
FDA listed 4 observations on this Form 483. The opening words of each observation are shown on this page.
Who inspected Cetero Research?
Carol M. Rivera-Lopez, Jacqueline A. Oshaughnessy and Patrick Stone are named on this Form 483, for the inspection of May 3 – May 7, 2010. Each investigator has a profile showing what they cite most.
When was Cetero Research inspected by FDA?
The inspection ran May 3 – May 7, 2010, and the Form 483 is dated May 7, 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.