Overview
- 7 FDA inspections are on record.
- 6 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-01-22.
At a glance
Inspections
7
Form 483s
6
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 12 Jan 2026 – 22 Jan 2026 | Human Drugs | 483 | View 483 → |
| 12 Nov 2024 – 19 Nov 2024 | Human Drugs | WL | On file |
| 29 Jun 2023 – 7 Jul 2023 | Human Drugs | 483 | On file |
| 4 Dec 2017 – 8 Dec 2017 | Human Drugs | Clean | |
| 9 Sep 2016 – 16 Sep 2016 | Human Drugs | 483 | On file |
| 2 Feb 2015 – 10 Feb 2015 | Human Drugs | 483 | On file |
| 19 Jul 2012 | Not recorded | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
Written in-process control procedures
Cited by Justin A Boyd, Khoa Nathan V Tran, Karen A Briggs
Procedures for sterile drug products
Cited by Justin A Boyd, Khoa Nathan V Tran, Karen A Briggs
Validation lacking for sterile drug products
Cited by Justin A Boyd, Khoa Nathan V Tran, Karen A Briggs
Review of representative number of batches
Cited by Justin A Boyd, Khoa Nathan V Tran, Karen A Briggs
Investigations of discrepancies, failures
Cited by Justin A Boyd, Khoa Nathan V Tran, Karen A Briggs
Investigators
FDA investigators tied to this site in the record.
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 | 6x |
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.160(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.186(b)(7) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.42(c)(10)(iv) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.42(c)(10)(v) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.42(c)(10)(vi) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.180(e)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(10)(i) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Excel Vision'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