Stason Pharmaceuticals, Inc
Form 483 issued October 25, 2019 · Irvine, California
- Inspection
- Oct 3 – Oct 25, 2019
- Investigators
- Cynthia Jim· Walden H. Lee
- Observations
- 15
- Pages
- 11
- FEI number
- 1000160561
In short: On October 25, 2019, FDA issued a Form 483 with 15 observations to Stason Pharmaceuticals, Inc in Irvine, California (FEI 1000160561) after an inspection that ran Oct 3 – Oct 25, 2019. The investigators were Cynthia Jim and Walden H. Lee. Most observations concern facilities & equipment and quality system; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
Facilities & equipment and quality system account for 9 of 15 observations.
Most cited: 21 CFR 211.192 (2×) · 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
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory…
- 02
Drug products do not bear an expiration date determined by appropriate stability data to assure they…
- 03
The responsibilities and procedures applicable to the quality control unit…
- 04
There is a failure to thoroughly review the failure of a batch or any of its…
This inspection in context
Cynthia Jim
20 documents · 2012–2024
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in North Carolina.
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 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Stason Pharmaceuticals, Inc?
FDA listed 15 observations on this Form 483, mostly about facilities & equipment, quality system and laboratory controls. The most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit). The opening words of each observation are shown on this page.
Who inspected Stason Pharmaceuticals, Inc?
Cynthia Jim and Walden H. Lee are named on this Form 483, for the inspection of Oct 3 – Oct 25, 2019. Each investigator has a profile showing what they cite most.
When was Stason Pharmaceuticals, Inc inspected by FDA?
The inspection ran Oct 3 – Oct 25, 2019, and the Form 483 is dated October 25, 2019.
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.