Quasar Bio-Tech, Inc

FDA inspection history across 2 sites, 2011 to 2024

1
Form 483
1
Warning letter

Every document, by year

  • Form 483
  • Warning letter

2011: one warning letter; 2024: one Form 483.

The story so far

Built from the dates and citations on the documents themselves.

  1. 2011One warning letter, at Sarasota, Florida.
  2. 2024One Form 483, at Yorba Linda, California.

Cited most

Across all Quasar Bio-Tech observations on file

The complete Quasar Bio-Tech file.

All 2 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.

$198

The price of the documents, added to your cart together

Sites

Documents

2 on file, newest first
DateDocumentPrice
2024-12-20483 Form 483$99
2011-12-09Warning letter Warning letter$99

Investigators on these documents

Jae H. Lee (1)Marlo-Ian M. Alintanahin (1)

FEI number 3006182559 · most recent document Dec 20, 2024

About Quasar Bio-Tech, Inc

How many FDA Form 483s has Quasar Bio-Tech, Inc received?

FDA Intel has 1 Form 483 on file for Quasar Bio-Tech, Inc; the most recent is dated Dec 20, 2024.

When was Quasar Bio-Tech, Inc last inspected by FDA?

The most recent FDA inspection document on file for Quasar Bio-Tech, Inc is a Form 483 dated Dec 20, 2024, for the site in Yorba Linda, California.

What did FDA cite at Quasar Bio-Tech, Inc?

The regulations cited most in the observations on file for Quasar Bio-Tech, Inc are 21 CFR 820.198(a) (Complaint files), 1 time; 21 CFR 820.22 (Quality audit), 1 time; 21 CFR 820.40 (Document controls), 1 time.

Has Quasar Bio-Tech, Inc received an FDA warning letter?

Yes. FDA Intel has 1 FDA warning letter on file for Quasar Bio-Tech, Inc; the most recent is dated Dec 9, 2011.