Overview
- 10 FDA inspections are on record.
- 7 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-11-04.
At a glance
Inspections
10
Form 483s
7
EIRs
1
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 → |
| 16 Sep 2024 – 19 Sep 2024 | Biologics | 483 | On file |
| 14 Feb 2024 – 21 Feb 2024 | Biologics | 483 | On file |
| 15 Nov 2022 – 22 Nov 2022 | Biologics | Clean | |
| 15 Jun 2021 – 2 Jul 2021 | Human Drugs | 483 | View 483 → |
| 11 Jun 2018 – 20 Jun 2018 | Human Drugs | Clean | |
| 18 Nov 2015 – 3 Dec 2015 | Human Drugs | Clean | |
| 13 Nov 2014 – 24 Nov 2014 | Human Drugs | 483 | View 483 → |
| 20 Aug 2013 – 28 Aug 2013 | Human Drugs | 483 | On file |
| 13 Feb 2013 – 22 Feb 2013 | Human Drugs | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
4 Nov 2025
21 CFR 211.113(b)
Validation lacking for sterile drug products
Cited by Jacob G Lutz, Beatrix D Hippe
4 Nov 2025
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Jacob G Lutz, Beatrix D Hippe
2 Jul 2021
21 CFR 211.110(a)
Control procedures to monitor and validate performance
Cited by Bei Y He, Charles L Zhou, Lisa R Hilliard, Joseph A Piechocki
2 Jul 2021
21 CFR 211.110(a)
Control procedures to monitor and validate performance
Cited by Bei Y He, Charles L Zhou, Lisa R Hilliard, Joseph A Piechocki
2 Jul 2021
21 CFR 211.160(b)
Scientifically sound laboratory controls
Cited by Bei Y He, Charles L Zhou, Lisa R Hilliard, Joseph A Piechocki
Investigators
FDA investigators tied to this site in the record.
Bei Y He2 insp.
Charles L Zhou2 insp.
Jacob G Lutz1 insp.
Beatrix D Hippe1 insp.
Wei Wang1 insp.
Neetu Dahiya1 insp.
Burnell M Henry1 insp.
Alan L Truong1 insp.
Susan M Jackson1 insp.
Hector A Carrero1 insp.
Ou Ma1 insp.
Lisa R Hilliard1 insp.
Joseph A Piechocki1 insp.
Constantin Y Philopoulos1 insp.
Michele L Forster1 insp.
Rebecca E Dombrowski1 insp.
Jeffrey D Meng1 insp.
Andrew J Idzior1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.22(a) | 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 211.58 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.80(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.63 | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Grand River Aseptic Manufacturing, Inc.'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