Stason Pharmaceuticals, Inc
Form 483 issued April 13, 2021 · Irvine, California
- Inspection
- Apr 1 – Apr 13, 2021
- Investigator
- Truong X. Nguyen
- Observations
- 2
- Pages
- 1
- FEI number
- 1000160561
In short: On April 13, 2021, FDA issued a Form 483 with 2 observations to Stason Pharmaceuticals, Inc in Irvine, California (FEI 1000160561) after an inspection that ran Apr 1 – Apr 13, 2021. The investigator was Truong X. Nguyen. Most observations concern quality system; the most-cited regulation is 21 CFR 211.25 (personnel qualifications).
At a glance
2 of 2 observations on this 483 concern quality system.
Most cited: 21 CFR 211.25(a) (1×) · 211.22(d) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Employees engaged in the manufacture, processing, packing and holding of a drug product lack the training…
- 02
The responsibilities and procedures applicable to the quality control unit…
This inspection in context
Truong X. Nguyen
20 documents · 2011–2026
Cites 211.22(d) (responsibilities of quality control unit) 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 211.25(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Stason Pharmaceuticals, Inc?
FDA listed 2 observations on this Form 483, mostly about quality system. The most-cited regulation is 21 CFR 211.25 (personnel qualifications). The opening words of each observation are shown on this page.
Who inspected Stason Pharmaceuticals, Inc?
Truong X. Nguyen is named on this Form 483, for the inspection of Apr 1 – Apr 13, 2021. Each investigator has a profile showing what they cite most.
When was Stason Pharmaceuticals, Inc inspected by FDA?
The inspection ran Apr 1 – Apr 13, 2021, and the Form 483 is dated April 13, 2021.
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.