Novartis Gene Therapies, Inc.
Form 483 issued August 27, 2021 · SAN DIEGO, California
- Inspection
- Aug 17 – Aug 27, 2021
- Investigators
- Eileen A. Liu· Linda Thai
- Observations
- 1
- Pages
- 3
- FEI number
- 3014617030
In short: On August 27, 2021, FDA issued a Form 483 with 1 observation to Novartis Gene Therapies, Inc. in SAN DIEGO, California (FEI 3014617030) after an inspection that ran Aug 17 – Aug 27, 2021. The investigators were Eileen A. Liu and Linda Thai. Most observations concern laboratory controls; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
1 of 1 observations on this 483 concern laboratory controls.
Most cited: 21 CFR 211.160 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Written procedures for the control of laboratory reagents are…
This inspection in context
Eileen A. Liu
41 documents · 2014–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in India.
The firmNovartis Gene Therapies, Inc. history
All 5 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.160
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Novartis Gene Therapies, Inc.?
FDA listed 1 observation on this Form 483, mostly about laboratory controls. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
Who inspected Novartis Gene Therapies, Inc.?
Eileen A. Liu and Linda Thai are named on this Form 483, for the inspection of Aug 17 – Aug 27, 2021. Each investigator has a profile showing what they cite most.
When was Novartis Gene Therapies, Inc. inspected by FDA?
The inspection ran Aug 17 – Aug 27, 2021, and the Form 483 is dated August 27, 2021.
How do I get the full Form 483 for Novartis Gene Therapies, 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.