Overview
- 8 FDA inspections are on record.
- 8 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-07-03.
At a glance
Inspections
8
Form 483s
8
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 23 Jun 2025 – 3 Jul 2025 | Human Drugs | 483 | View 483 → |
| 1 Nov 2023 – 17 Nov 2023 | Human Drugs | 483 | View 483 → |
| 16 Nov 2021 – 3 Dec 2021 | Human Drugs | 483 | View 483 → |
| 10 Dec 2018 – 19 Dec 2018 | Human Drugs | 483 | View 483 → |
| 7 Jun 2017 – 15 Jun 2017 | Human Drugs | 483 | View 483 → |
| 15 Sep 2014 – 7 Oct 2014 | Human Drugs | 483 | View 483 → |
| 18 Feb 2014 – 6 Mar 2014 | Human Drugs | 483 | View 483 → |
| 22 Oct 2013 – 5 Nov 2013 | Human Drugs | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
3 Jul 2025
21 CFR 211.100(a)
Absence of Written Procedures
Cited by Jolanna A Norton, Matthew R Clabeaux
3 Jul 2025
21 CFR 211.113(b)
Procedures for sterile drug products
Cited by Jolanna A Norton, Matthew R Clabeaux
3 Jul 2025
21 CFR 211.166(a)(4)
Testing in same container - closure system
Cited by Jolanna A Norton, Matthew R Clabeaux
3 Jul 2025
21 CFR 211.25(a)
Training--operations, GMPs, written procedures
Cited by Jolanna A Norton, Matthew R Clabeaux
3 Jul 2025
21 CFR 211.42(c)(10)(iv)
Environmental Monitoring System
Cited by Jolanna A Norton, Matthew R Clabeaux
Investigators
FDA investigators tied to this site in the record.
Jolanna A Norton2 insp.
Ashar P Parikh2 insp.
Anh Lac2 insp.
Matthew R Clabeaux1 insp.
Jeffrey P Raimondi1 insp.
Andrew Le1 insp.
Anney Lin1 insp.
Lisa Shin1 insp.
Alicia K Mckinsey1 insp.
Henry K Lau1 insp.
Thomas J Arista1 insp.
Jennifer H Rhyu1 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 | 8x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.42(c)(10)(iv) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.42(c)(10)(v) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.28(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.103 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.115(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(a)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.167(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.170(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.186(b)(5) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.186(b)(9) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(10)(vi) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.56(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(e) | Cited across public-safe Form 483 observations | 1x |
| FDCA 503B(a)(10)(A) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Wedgewood Connect, LLC's 8 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