Overview
- 6 FDA inspections are on record.
- 6 inspections produced a Form 483.
- The most recent recorded inspection date is 2023-11-10.
At a glance
Inspections
6
Form 483s
6
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 6 Nov 2023 – 10 Nov 2023 | Human Drugs | 483 | View 483 → |
| 4 Feb 2020 – 7 Feb 2020 | Biologics | 483 | On file |
| 19 Aug 2019 – 28 Aug 2019 | Human Drugs | 483 | On file |
| 30 Jul 2018 – 8 Aug 2018 | Human Drugs | 483 | View 483 → |
| 19 Jul 2013 – 26 Jul 2013 | Animal Drugs & Feeds | 483 | On file |
| 17 Jul 2012 | Not recorded | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
8 Aug 2018
21 CFR 211.113(b)
Procedures for sterile drug products
Cited by Joshua P Wireman, Katherine D Adams
8 Aug 2018
21 CFR 211.42(c)(10)(iv)
Environmental Monitoring System
Cited by Joshua P Wireman, Katherine D Adams
Investigators
FDA investigators tied to this site in the record.
Libia M Lugo1 insp.
Eileen A Liu1 insp.
Debra M Emerson1 insp.
Jie He1 insp.
Kristin M Abaonza1 insp.
Joshua P Wireman1 insp.
Katherine D Adams1 insp.
Binh T Nguyen1 insp.
Michael R Klapal1 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 | 2x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(10)(iv) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Resilience Biotechnologies, Inc.'s 6 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