Novartis Gene Therapies, Inc.
Form 483 issued August 2, 2019 · SAN DIEGO, California
- Inspection
- Jul 24 – Aug 2, 2019
- Investigators
- Mihaly S. Ligmond· Scott Ballard
- Observations
- 5
- Pages
- 5
- FEI number
- 3014617030
In short: On August 2, 2019, FDA issued a Form 483 with 5 observations to Novartis Gene Therapies, Inc. in SAN DIEGO, California (FEI 3014617030) after an inspection that ran Jul 24 – Aug 2, 2019. The investigators were Mihaly S. Ligmond and Scott Ballard. Most observations concern laboratory controls and quality system; the most-cited regulation is 21 CFR 211.194 (laboratory records).
At a glance
3 of 5 observations on this 483 concern laboratory controls.
What FDA observed
Preview: the opening words of each observation- 01
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has…
- 02
Laboratory records do not include complete data derived from all tests, examinations and assay necessary to…
- 03
The responsibilities and procedures applicable to the quality control unit…
- 04
Laboratory records do not include complete records of any testing and standardization…
This inspection in context
Mihaly S. Ligmond
20 documents · 2006–2024
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Ireland.
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 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Novartis Gene Therapies, Inc.?
FDA listed 5 observations on this Form 483, mostly about laboratory controls and quality system. The most-cited regulation is 21 CFR 211.194 (laboratory records). The opening words of each observation are shown on this page.
Who inspected Novartis Gene Therapies, Inc.?
Mihaly S. Ligmond and Scott Ballard are named on this Form 483, for the inspection of Jul 24 – Aug 2, 2019. Each investigator has a profile showing what they cite most.
When was Novartis Gene Therapies, Inc. inspected by FDA?
The inspection ran Jul 24 – Aug 2, 2019, and the Form 483 is dated August 2, 2019.
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.