Stason Pharmaceuticals, Inc
Form 483 issued March 8, 2016 · Irvine, California
- Inspection
- Feb 22 – Mar 8, 2016
- Investigators
- Joey V. Quitania· Walden H. Lee
- Observations
- 7
- Pages
- 4
- FEI number
- 1000160561
In short: On March 8, 2016, FDA issued a Form 483 with 7 observations to Stason Pharmaceuticals, Inc in Irvine, California (FEI 1000160561) after an inspection that ran Feb 22 – Mar 8, 2016. The investigators were Joey V. Quitania and Walden H. Lee. Most observations concern laboratory controls and facilities & equipment; the most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment).
At a glance
Observations span 4 systems, led by laboratory controls.
Most cited: 21 CFR 211.68 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Written records of investigations into unexplained discrepancies and the failure of a batch or any of…
- 02
The accuracy, sensitivity, specificity, and reproducibility of test methods have not…
- 03
Appropriate controls are not exercised over computers or related systems to assure that changes in master…
- 04
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to…
This inspection in context
Joey V. Quitania
23 documents · 2009–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in California.
The firmStason Pharmaceuticals, Inc history
All 5 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.68
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Stason Pharmaceuticals, Inc?
FDA listed 7 observations on this Form 483, mostly about laboratory controls, facilities & equipment and production. The most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment). The opening words of each observation are shown on this page.
Who inspected Stason Pharmaceuticals, Inc?
Joey V. Quitania and Walden H. Lee are named on this Form 483, for the inspection of Feb 22 – Mar 8, 2016. Each investigator has a profile showing what they cite most.
When was Stason Pharmaceuticals, Inc inspected by FDA?
The inspection ran Feb 22 – Mar 8, 2016, and the Form 483 is dated March 8, 2016.
How do I get the full Form 483 for Stason Pharmaceuticals, Inc?
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.