Form 483 · FEI 3007500366
Form 483 issued December 16, 2016 · Spokane, Washington
- Inspection
- Dec 6 – Dec 16, 2016
- Investigator
- Gerard P. De Leon
- Observations
- 4
- Pages
- 3
- FEI number
- 3007500366
In short: On December 16, 2016, FDA issued a Form 483 with 4 observations to an FDA-inspected site in Spokane, Washington (FEI 3007500366) after an inspection that ran Dec 6 – Dec 16, 2016. The investigator was Gerard P. De Leon. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
3 of 4 observations on this 483 concern facilities & equipment.
Most cited: 21 CFR 211.42 (3×) · 211.113 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The I SO-classified areas have difficult to clean, particle-generating, or visibly…
- 02
Sinks or drains are present in the cleanroom where the ISO…
- 03
The ISO 5 area is located…
- 04
ISO 5 classified areas were not…
This inspection in context
Gerard P. De Leon
9 documents · 2015–2017
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 5 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.42
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 production. 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?
Gerard P. De Leon is named on this Form 483, for the inspection of Dec 6 – Dec 16, 2016. Each investigator has a profile showing what they cite most.
When was an FDA-inspected site inspected by FDA?
The inspection ran Dec 6 – Dec 16, 2016, and the Form 483 is dated December 16, 2016.
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.