Overview
- 16 FDA inspections are on record.
- 6 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-02-28.
At a glance
Inspections
16
Form 483s
6
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 24 Feb 2025 – 28 Feb 2025 | Human Drugs | 483 | View 483 → |
| 7 Mar 2022 – 22 Mar 2022 | Human Drugs | 483 | View 483 → |
| 15 Apr 2019 – 18 Apr 2019 | Human Drugs | 483 | On file |
| 12 Feb 2018 – 16 Feb 2018 | Human Drugs | Clean | |
| 27 Feb 2017 – 3 Mar 2017 | Human Drugs | 483 | View 483 → |
| 27 Jul 2015 – 31 Jul 2015 | Human Drugs | 483 | On file |
| 15 Apr 2014 – 17 Apr 2014 | Human Drugs | Clean | |
| 9 Sep 2011 | Not recorded | Clean | |
| 6 Jan 2011 | Not recorded | 483 | On file |
| 30 Sep 2010 | Not recorded | Clean | |
| 12 Aug 2010 | Not recorded | Clean | |
| 18 Sep 2009 | Not recorded | Clean | |
Observations on record
Form 483 observations cited at this site, most recent first.
28 Feb 2025
21 CFR 211.113(b)
Validation lacking for sterile drug products
Cited by Veronica Fuentes, Andrew O Ejiofor
28 Feb 2025
21 CFR 211.192
Investigations of discrepancies, failures
Cited by Veronica Fuentes, Andrew O Ejiofor
28 Feb 2025
21 CFR 211.42(c)
Defined areas of adequate size for operations
Cited by Veronica Fuentes, Andrew O Ejiofor
3 Mar 2017
21 CFR 211.160(a)
Following/documenting laboratory controls
Cited by Jared P Stevens, Larry K Hampton, Claudette D Brooks
Investigators
FDA investigators tied to this site in the record.
Jared P Stevens3 insp.
Bonita S Chester3 insp.
Ibad U Khan2 insp.
Veronica Fuentes1 insp.
Andrew O Ejiofor1 insp.
Yiyue Zhang1 insp.
Rachael L Cook1 insp.
Jonathan G Swoboda1 insp.
Larry K Hampton1 insp.
Claudette D Brooks1 insp.
Hai Lien T Phung1 insp.
Gabriel R Mclemore1 insp.
Jason F Chancey1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.160(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.100(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.20(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.20(c) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.30(j) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind The Ritedose Corporation's 6 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