Liveyon
Form 483 issued September 21, 2018 · Yorba Linda, California
- Inspection
- Sep 17 – Sep 21, 2018
- Investigators
- Tania Y. Hall· Thanh B. Tran
- Observations
- 8
- Pages
- 6
- FEI number
- 3013957857
In short: On September 21, 2018, FDA issued a Form 483 with 8 observations to Liveyon in Yorba Linda, California (FEI 3013957857) after an inspection that ran Sep 17 – Sep 21, 2018. The investigators were Tania Y. Hall and Thanh B. Tran. Most observations concern hCT/P and quality system; the most-cited regulation is 21 CFR 1271.265 (receipt, predistribution shipment, and distribution of an HCT/P).
At a glance
6 of 8 observations on this 483 concern hct/p.
What FDA observed
Preview: the opening words of each observation- 01
Adverse reactions which involved a communicable disease related to an HCT/P made available for distribution and…
- 02
Complaint records are deficient in that they do not include the findings of the…
- 03
The swnmary of records for HCT/Ps did not contain an interpretation of results of all…
- 04
Release criteria were not verified to have been met through a review of manufacturing and tracking…
This inspection in context
Tania Y. Hall
5 documents · 2003–2019
Cites 211.198(a) (complaint files) 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 1271.350(a)(1)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Liveyon?
FDA listed 8 observations on this Form 483, mostly about hCT/P, quality system and laboratory controls. The most-cited regulation is 21 CFR 1271.265 (receipt, predistribution shipment, and distribution of an HCT/P). The opening words of each observation are shown on this page.
Who inspected Liveyon?
Tania Y. Hall and Thanh B. Tran are named on this Form 483, for the inspection of Sep 17 – Sep 21, 2018. Each investigator has a profile showing what they cite most.
When was Liveyon inspected by FDA?
The inspection ran Sep 17 – Sep 21, 2018, and the Form 483 is dated September 21, 2018.
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.