Overview
- 8 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-02-16.
At a glance
Inspections
8
Form 483s
2
EIRs
3
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 12 Feb 2024 – 16 Feb 2024 | Human Drugs | Clean | |
| 29 Jan 2024 – 1 Feb 2024 | Human Drugs | Clean | |
| 20 Mar 2023 – 31 Mar 2023 | Human Drugs | Clean | |
| 30 Jun 2021 – 8 Jul 2021 | Human Drugs | 483 | View 483 → |
| 23 Jan 2019 – 4 Feb 2019 | Human Drugs | 483 | On file |
| 7 Sep 2018 – 11 Sep 2018 | Human Drugs | Clean | |
| 2 May 2018 – 9 May 2018 | Human Drugs | Clean | |
| 7 Aug 2017 – 11 Aug 2017 | Human Drugs | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
8 Jul 2021
21 CFR 211.110(a)
Written in-process control procedures
Cited by Nicholas A Violand, Annet R Rajan, Robin P Mathew
Investigators
FDA investigators tied to this site in the record.
Annet R Rajan2 insp.
Gabrielle J Swain1 insp.
Juanita P Versace1 insp.
Naveen B Kanthamneni1 insp.
Tanya R Syffrard1 insp.
Nicholas A Violand1 insp.
Robin P Mathew1 insp.
Frederick Razzaghi1 insp.
Melissa T Roy1 insp.
Emmanuel J Ramos1 insp.
Russell J Glapion1 insp.
Paul L Bellamy1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Novitium Pharma LLC's 2 Form 483s
Source PDFs 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