Quasar Bio-Tech, Inc
Form 483 issued December 20, 2024 · Yorba Linda, California
- Inspection
- Dec 16 – Dec 20, 2024
- Investigators
- Jae H. Lee· Marlo-Ian M. Alintanahin
- Observations
- 4
- Pages
- 5
- FEI number
- 3006182559
In short: On December 20, 2024, FDA issued a Form 483 with 4 observations to Quasar Bio-Tech, Inc in Yorba Linda, California (FEI 3006182559) after an inspection that ran Dec 16 – Dec 20, 2024. The investigators were Jae H. Lee and Marlo-Ian M. Alintanahin. Most observations concern management controls and production & process controls.
At a glance
Observations span 4 systems, led by management controls.
What FDA observed
Preview: the opening words of each observation- 01
Quality audits were not performed at defined intervals to determine whether the quality system activities and…
- 02
There is no agreement with suppliers to notify you of changes in…
- 03
Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have…
- 04
Document control procedures have…
This inspection in context
Jae H. Lee
3 documents · 2024–2026
Cites 820.50 (purchasing controls) more than any other section. Most of their documents are for sites in California.
The firmQuasar Bio-Tech, 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 820.22
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Quasar Bio-Tech, Inc?
FDA listed 4 observations on this Form 483, mostly about management controls, production & process controls and cAPA. The opening words of each observation are shown on this page.
Who inspected Quasar Bio-Tech, Inc?
Jae H. Lee and Marlo-Ian M. Alintanahin are named on this Form 483, for the inspection of Dec 16 – Dec 20, 2024. Each investigator has a profile showing what they cite most.
When was Quasar Bio-Tech, Inc inspected by FDA?
The inspection ran Dec 16 – Dec 20, 2024, and the Form 483 is dated December 20, 2024.
How do I get the full Form 483 for Quasar Bio-Tech, Inc?
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.