Liveyon Labs Inc.
Form 483 issued May 23, 2019 · Yorba Linda, California
- Inspection
- May 13 – May 23, 2019
- Investigators
- Abby L. Mozeke-Baker· Tania Y. Hall
- Observations
- 9
- Pages
- 12
- FEI number
- 3015381220
In short: On May 23, 2019, FDA issued a Form 483 with 9 observations to Liveyon Labs Inc. in Yorba Linda, California (FEI 3015381220) after an inspection that ran May 13 – May 23, 2019. The investigators were Abby L. Mozeke-Baker and Tania Y. Hall. Most observations concern hCT/P and production; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Observations span 4 systems, led by hct/p.
What FDA observed
Preview: the opening words of each observation- 01
Donors were not screened by a review of relevant medical records for risk factors of communicable…
- 02
HCT/P donors were not determined to be eligible based on the results of…
- 03
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include…
- 04
Equipment and utensils are not cleaned at appropriate intervals to prevent contamination that would alter the…
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 Labs 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 1271.75(a)(1)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Liveyon Labs Inc.?
FDA listed 9 observations on this Form 483, mostly about hCT/P, production and quality system. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
Who inspected Liveyon Labs Inc.?
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 Labs Inc. 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 Labs Inc.?
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