Liveyon
Form 483 issued May 23, 2019 · Yorba Linda, California
- Inspection
- May 13 – May 23, 2019
- Investigators
- Abby L. Mozeke-Baker· Tania Y. Hall
- Observations
- 1
- Pages
- 1
- FEI number
- 3013957857
In short: On May 23, 2019, FDA issued a Form 483 with 1 observation to Liveyon in Yorba Linda, California (FEI 3013957857) after an inspection that ran May 13 – May 23, 2019. The investigators were Abby L. Mozeke-Baker and Tania Y. Hall. Most observations concern quality system; the most-cited regulation is 21 CFR 211.198 (complaint files).
At a glance
1 of 1 observations on this 483 concern quality system.
Most cited: 21 CFR 211.198(a) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Procedures describing the handling of written and oral complaints related to drug products are…
This inspection in context
Abby L. Mozeke-Baker
3 documents · 2016–2019
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in California.
The firmLiveyon history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.198(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Liveyon?
FDA listed 1 observation on this Form 483, mostly about quality system. The most-cited regulation is 21 CFR 211.198 (complaint files). The opening words of each observation are shown on this page.
Who inspected Liveyon?
Abby L. Mozeke-Baker and Tania Y. Hall are named on this Form 483, for the inspection of May 13 – May 23, 2019. Each investigator has a profile showing what they cite most.
When was Liveyon inspected by FDA?
The inspection ran May 13 – May 23, 2019, and the Form 483 is dated May 23, 2019.
How do I get the full Form 483 for Liveyon?
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.