American Regent, Inc.
Form 483 issued January 25, 2019 · Brea, California
- Inspection
- Jan 7 – Jan 25, 2019
- Investigators
- Haitao Li· Linda Thai
- Observations
- 8
- Pages
- 9
- FEI number
- 3011148804
In short: On January 25, 2019, FDA issued a Form 483 with 8 observations to American Regent, Inc. in Brea, California (FEI 3011148804) after an inspection that ran Jan 7 – Jan 25, 2019. The investigators were Haitao Li and Linda Thai. Most observations concern production and quality system.
At a glance
Production and quality system account for 5 of 8 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The accuracy, sensitivity, specificity and reproducibility of test methods have not…
- 02
Backup data is not assured as exact, complete and secure from alteration, erasure or loss through…
- 03
The batch production and control records do not include a statement of the actual yield and…
- 04
Master production and control records lack complete manufacturing and control instructions, sampling and testing procedures, special…
This inspection in context
Haitao Li
5 documents · 2019–2024
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in India.
The firmAmerican Regent, 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 211.165
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at American Regent, Inc.?
FDA listed 8 observations on this Form 483, mostly about production, quality system and laboratory controls. The opening words of each observation are shown on this page.
Who inspected American Regent, Inc.?
Haitao Li and Linda Thai are named on this Form 483, for the inspection of Jan 7 – Jan 25, 2019. Each investigator has a profile showing what they cite most.
When was American Regent, Inc. inspected by FDA?
The inspection ran Jan 7 – Jan 25, 2019, and the Form 483 is dated January 25, 2019.
How do I get the full Form 483 for American Regent, 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.