Form 483 · FEI 3014577316
Form 483 issued October 5, 2020 · Tukwila, Washington
- Inspection
- Sep 8 – Oct 5, 2020
- Investigators
- Kenneth O. Gee· Nathaniel B. Phillips-Sylvain
- Observations
- 4
- Pages
- 5
- FEI number
- 3014577316
In short: On October 5, 2020, FDA issued a Form 483 with 4 observations to an FDA-inspected site in Tukwila, Washington (FEI 3014577316) after an inspection that ran Sep 8 – Oct 5, 2020. The investigators were Kenneth O. Gee and Nathaniel B. Phillips-Sylvain. Most observations concern facilities & equipment and laboratory controls; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Observations span 2 systems, led by facilities & equipment.
What FDA observed
Preview: the opening words of each observation- 01
Aseptic processing areas are deficient regarding the system…
- 02
Each batch of drug product purporting to be sterile and pyrogen-free is not laboratory tested to…
- 03FDCA 503B(b)(2)(A)
Your outsourcing facility did not submit a report to FDA identifying the drugs compounded during the…
- 04FDCA 503B(a)(10)
The labels of your outsourcing facility's…
This inspection in context
Kenneth O. Gee
9 documents · 2017–2022
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Washington.
The firmSite history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.42(c)(10)(iv)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at an FDA-inspected site?
FDA listed 4 observations on this Form 483, mostly about facilities & equipment and laboratory controls. The most-cited regulation is 21 CFR 211.42 (design and construction features). The opening words of each observation are shown on this page.
Who inspected an FDA-inspected site?
Kenneth O. Gee and Nathaniel B. Phillips-Sylvain are named on this Form 483, for the inspection of Sep 8 – Oct 5, 2020. Each investigator has a profile showing what they cite most.
When was an FDA-inspected site inspected by FDA?
The inspection ran Sep 8 – Oct 5, 2020, and the Form 483 is dated October 5, 2020.
How do I get the full Form 483 for an FDA-inspected site?
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.