Overview
- 4 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-11-04.
At a glance
Inspections
4
Form 483s
2
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 27 Oct 2025 – 4 Nov 2025 | Human Drugs | 483 | View 483 → |
| 19 Feb 2024 – 21 Feb 2024 | Biologics | Clean | |
| 27 Sep 2023 – 29 Sep 2023 | Human Drugs | 483 | On file |
| 15 Nov 2022 – 22 Nov 2022 | Biologics | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
4 Nov 2025
21 CFR 211.110(a)
Control procedures to monitor and validate performance
Cited by Jacob G Lutz
29 Sep 2023
21 CFR 211.110(a)
Control procedures to monitor and validate performance
Cited by Jacob G Lutz
Investigators
FDA investigators tied to this site in the record.
Jacob G Lutz2 insp.
Burnell M Henry1 insp.
Alan L Truong1 insp.
Susan M Jackson1 insp.
Hector A Carrero1 insp.
Ou Ma1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Grand River Aseptic Manufacturing Inc.'s 2 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