Physic-Control, Inc
Form 483 issued December 15, 2017 · Redmond, Washington
- Inspection
- Nov 27 – Dec 15, 2017
- Investigators
- Paul M. Kawamoto· Stephen R. Souza
- Observations
- 2
- Pages
- 2
- FEI number
- 3015876
In short: On December 15, 2017, FDA issued a Form 483 with 2 observations to Physic-Control, Inc in Redmond, Washington (FEI 3015876) after an inspection that ran Nov 27 – Dec 15, 2017. The investigators were Paul M. Kawamoto and Stephen R. Souza. Most observations concern cAPA; the most-cited regulation is 21 CFR 820.100 (corrective and preventive action).
At a glance
2 of 2 observations on this 483 concern capa.
Most cited: 21 CFR 820.100(a) (1×) · 803.56 (1×)
What FDA observed
Preview: the opening words of each observation- 01
Procedures for corrective and preventive action have…
- 02
A supplemental report was not submitted to FDA within one month following receipt of information that…
This inspection in context
Paul M. Kawamoto
7 documents · 2015–2021
Cites 820.100 (corrective and preventive action) more than any other section. Most of their documents are for sites in Washington.
The firmPhysic-Control, Inc history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 820.100(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Physic-Control, Inc?
FDA listed 2 observations on this Form 483, mostly about cAPA. The most-cited regulation is 21 CFR 820.100 (corrective and preventive action). The opening words of each observation are shown on this page.
Who inspected Physic-Control, Inc?
Paul M. Kawamoto and Stephen R. Souza are named on this Form 483, for the inspection of Nov 27 – Dec 15, 2017. Each investigator has a profile showing what they cite most.
When was Physic-Control, Inc inspected by FDA?
The inspection ran Nov 27 – Dec 15, 2017, and the Form 483 is dated December 15, 2017.
How do I get the full Form 483 for Physic-Control, 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.