Physic-Control, Inc
Form 483 issued November 26, 2019 · Redmond, Washington
- Inspection
- Nov 5 – Nov 26, 2019
- Investigators
- James A. Lane· Stephen R. Souza
- Observations
- 5
- Pages
- 4
- FEI number
- 3015876
In short: On November 26, 2019, FDA issued a Form 483 with 5 observations to Physic-Control, Inc in Redmond, Washington (FEI 3015876) after an inspection that ran Nov 5 – Nov 26, 2019. The investigators were James A. Lane and Stephen R. Souza. Most observations concern cAPA and design controls.
At a glance
CAPA and design controls account for 3 of 5 observations.
What FDA observed
Preview: the opening words of each observation- 01
An individual medical device manufacturer report submitted per FDA Form 3500A did not indicate in Block…
- 02
Procedures for corrective and preventive action have…
- 03
Procedures for design verification have…
- 04
Potential suppliers were not evaluated based on their ability…
This inspection in context
James A. Lane
2 documents · 2011–2019
Cites 118.10 (recordkeeping requirements for the salmonella enteritidis (se) prevention plan) more than any other section. Most of their documents are for sites in Indiana.
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 803.52(b)(2)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Physic-Control, Inc?
FDA listed 5 observations on this Form 483, mostly about cAPA, design controls and production & process controls. The opening words of each observation are shown on this page.
Who inspected Physic-Control, Inc?
James A. Lane and Stephen R. Souza are named on this Form 483, for the inspection of Nov 5 – Nov 26, 2019. Each investigator has a profile showing what they cite most.
When was Physic-Control, Inc inspected by FDA?
The inspection ran Nov 5 – Nov 26, 2019, and the Form 483 is dated November 26, 2019.
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.