Elite Performance and Learning Center
Form 483 issued May 14, 2019 · Seattle, Washington
- Inspection
- May 6 – May 14, 2019
- Investigator
- Christopher S. Genther
- Observations
- 8
- Pages
- 6
- FEI number
- 3014207250
In short: On May 14, 2019, FDA issued a Form 483 with 8 observations to Elite Performance and Learning Center in Seattle, Washington (FEI 3014207250) after an inspection that ran May 6 – May 14, 2019. The investigator was Christopher S. Genther. Most observations concern cAPA and production & process controls.
At a glance
CAPA and production & process controls account for 6 of 8 observations.
What FDA observed
Preview: the opening words of each observation- 01
Written MDR procedures have not been developed. Your firm is a manufacturer of a biofeedback device…
- 02
Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit…
- 03
Procedures for design control…
- 04
Procedures for corrective and preventive action…
This inspection in context
Christopher S. Genther
4 documents · 2016–2022
Cites 803.17 (what are the requirements for developing, maintaining, and implementing written mdr procedures that apply to me?) more than any other section. Most of their documents are for sites in Washington.
The firmElite Performance and Learning Center history
The site's inspection history, in date order.
Similar 483sOther sites cited under 803.17
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Elite Performance and Learning Center?
FDA listed 8 observations on this Form 483, mostly about cAPA, production & process controls and design controls. The opening words of each observation are shown on this page.
Who inspected Elite Performance and Learning Center?
Christopher S. Genther is named on this Form 483, for the inspection of May 6 – May 14, 2019. Each investigator has a profile showing what they cite most.
When was Elite Performance and Learning Center inspected by FDA?
The inspection ran May 6 – May 14, 2019, and the Form 483 is dated May 14, 2019.
How do I get the full Form 483 for Elite Performance and Learning Center?
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.