Novartis Gene Therapies, Inc.
Form 483 issued January 26, 2024 · Durham, North Carolina
- Inspection
- Jan 17 – Jan 26, 2024
- Investigators
- Thai D. Truong· Unnee Ranjan
- Observations
- 2
- Pages
- 3
- FEI number
- 3015404862
In short: On January 26, 2024, FDA issued a Form 483 with 2 observations to Novartis Gene Therapies, Inc. in Durham, North Carolina (FEI 3015404862) after an inspection that ran Jan 17 – Jan 26, 2024. The investigators were Thai D. Truong and Unnee Ranjan. Most observations concern biologics CGMP and quality system; the most-cited regulation is 21 CFR 600.14 (reporting of biological product deviations by licensed manufacturers).
At a glance
Biologics CGMP and quality system account for 2 of 2 observations.
Most cited: 21 CFR 600.14(c) (1×) · 211.192 (1×)
What FDA observed
Preview: the opening words of each observation- 01
Biological product deviations are not reported within the…
- 02
Investigations of an unexplained discrepancy did not extend to other drug products that may have been…
This inspection in context
Thai D. Truong
12 documents · 2022–2025
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Massachusetts.
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 600.14(c)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Novartis Gene Therapies, Inc.?
FDA listed 2 observations on this Form 483, mostly about biologics CGMP and quality system. The most-cited regulation is 21 CFR 600.14 (reporting of biological product deviations by licensed manufacturers). The opening words of each observation are shown on this page.
Who inspected Novartis Gene Therapies, Inc.?
Thai D. Truong and Unnee Ranjan are named on this Form 483, for the inspection of Jan 17 – Jan 26, 2024. Each investigator has a profile showing what they cite most.
When was Novartis Gene Therapies, Inc. inspected by FDA?
The inspection ran Jan 17 – Jan 26, 2024, and the Form 483 is dated January 26, 2024.
How do I get the full Form 483 for Novartis Gene Therapies, Inc.?
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