Overview
- 5 FDA inspections are on record.
- 5 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-02-06.
At a glance
Inspections
5
Form 483s
5
EIRs
2
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 30 Jan 2026 – 6 Feb 2026 | Biologics | 483 | View 483 → |
| 30 Jul 2024 – 8 Aug 2024 | Biologics | 483 | View 483 → |
| 28 Nov 2022 – 9 Dec 2022 | Biologics | 483 | On file |
| 13 Aug 2019 – 21 Aug 2019 | Biologics | 483 | View 483 → |
| 3 Apr 2017 – 7 Apr 2017 | Biologics | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
6 Feb 2026
21 CFR 211.113(b)
Procedures for sterile drug products
Cited by Christian Lynch, Lizaida Perez
6 Feb 2026
21 CFR 211.192
Investigations of discrepancies, failures
Cited by Christian Lynch, Lizaida Perez
6 Feb 2026
21 CFR 211.67(a)
Cleaning / Sanitizing / Maintenance
Cited by Christian Lynch, Lizaida Perez
8 Aug 2024
21 CFR 211.160(b)
Scientifically sound laboratory controls
Cited by Unnee Ranjan, Laurel A Beer
Investigators
FDA investigators tied to this site in the record.
Unnee Ranjan2 insp.
Christian Lynch1 insp.
Lizaida Perez1 insp.
Laurel A Beer1 insp.
Thai D Truong1 insp.
Susan M Jackson1 insp.
Jacqueline M Diaz Albert1 insp.
Kimberly L Schultz1 insp.
Joan Johnson1 insp.
Ashley J Burns1 insp.
Randa Melhem1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.180(e)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Novartis Pharmaceuticals Corporation's 5 Form 483s
Source PDFs, verbatim observations, and recurring CFR citations, so your team knows what this site gets cited for.
- The site's full inspection history, with every Form 483 and its outcome
- Warning letters and recalls tied to the company behind it
- Whether recurring CFR citations get closed out or repeat