Overview
- 15 FDA inspections are on record.
- 7 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-01-21.
At a glance
Inspections
15
Form 483s
7
EIRs
1
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 16 Dec 2024 – 21 Jan 2025 | Human Drugs | 483 | View 483 → |
| 2 May 2022 – 25 May 2022 | Human Drugs | 483 | On file |
| 5 Aug 2019 – 9 Aug 2019 | Human Drugs | 483 | View 483 → |
| 5 Mar 2018 – 8 Mar 2018 | Human Drugs | 483 | View 483 → |
| 29 Aug 2017 – 7 Sep 2017 | Human Drugs | Clean | |
| 27 Jun 2017 | Human Drugs | Clean | |
| 10 Aug 2016 – 24 Aug 2016 | Human Drugs | Clean | |
| 3 Nov 2015 | Human Drugs | Clean | |
| 28 Jul 2015 | Human Drugs | Clean | |
| 7 Jul 2014 – 22 Jul 2014 | Human Drugs | 483 | View 483 → |
| 9 Apr 2013 | Human Drugs | Clean | |
| 11 Jul 2012 | Not recorded | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
21 Jan 2025
21 CFR 211.113(b)
Procedures for sterile drug products
Cited by Rafeeq A Habeeb, Karen A Briggs
21 Jan 2025
21 CFR 211.192
Investigations of discrepancies, failures
Cited by Rafeeq A Habeeb, Karen A Briggs
21 Jan 2025
21 CFR 211.194(a)
Complete test data included in records
Cited by Rafeeq A Habeeb, Karen A Briggs
21 Jan 2025
21 CFR 211.194(a)(8)
Identification of Person Performing Review of Lab Records
Cited by Rafeeq A Habeeb, Karen A Briggs
Investigators
FDA investigators tied to this site in the record.
Lindsey M Schwierjohann5 insp.
Lauren N Howard4 insp.
Anna M Brannen3 insp.
Christopher T Middendorf2 insp.
Nicholas L Paulin2 insp.
Elizabeth L Edwards2 insp.
Rafeeq A Habeeb1 insp.
Karen A Briggs1 insp.
Muna Algharibeh1 insp.
Courtney E Hillier1 insp.
Richard T Riggie1 insp.
Teresa K Kastner1 insp.
Lianji Jin1 insp.
Lauren N Smith1 insp.
Matt D Suedkamp1 insp.
Tracey L Harris1 insp.
Cherrie A Zachary1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.110(d) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.184(e) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.160(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.110(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.180(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.182 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a)(8) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(d)(6) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 314.81(b)(1)(i) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Resilience US, LLC's 7 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