EO Products, LLC
Form 483 issued November 17, 2020 · San Rafael, California
- Inspection
- Oct 27 – Nov 17, 2020
- Investigator
- Jolanna A. Norton
- Observations
- 3
- Pages
- 5
- FEI number
- 2915875
In short: On November 17, 2020, FDA issued a Form 483 with 3 observations to EO Products, LLC in San Rafael, California (FEI 2915875) after an inspection that ran Oct 27 – Nov 17, 2020. The investigator was Jolanna A. Norton. Most observations concern quality system and laboratory controls.
At a glance
Quality system and laboratory controls account for 2 of 3 observations.
What FDA observed
Preview: the opening words of each observation- 01
The responsibilities and procedures applicable to the quality control unit are not in…
- 02
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to…
- 03
Establishment of the reliability of the component supplier's report of analyses is deficient in that the…
This inspection in context
Jolanna A. Norton
22 documents · 2017–2026
Cites FDCA 501(a)(2)(A) (insanitary conditions) more than any other section. Most of their documents are for sites in California.
The firmEO Products, LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.22(d)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at EO Products, LLC?
FDA listed 3 observations on this Form 483, mostly about quality system, laboratory controls and materials. The opening words of each observation are shown on this page.
Who inspected EO Products, LLC?
Jolanna A. Norton is named on this Form 483, for the inspection of Oct 27 – Nov 17, 2020. Each investigator has a profile showing what they cite most.
When was EO Products, LLC inspected by FDA?
The inspection ran Oct 27 – Nov 17, 2020, and the Form 483 is dated November 17, 2020.
How do I get the full Form 483 for EO Products, LLC?
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.