Drug factory · FDA FEI 3008716173
Grand River Aseptic Manufacturing, Inc.
524 Butterworth St SW, Grand Rapids, MI, United States
Problems found, fixed voluntarily at FDA's last inspection, Nov 4, 2025.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
12 drug inspections on record since 2013: 2 with no problems, 4 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Cemiplimab | Makes it and tests it | Regeneron Pharmaceuticals, Inc. | 61755-008 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Nov 4, 2025 | Problems found, fixed voluntarily | Drug Quality Assurance | 4 |
| Nov 4, 2025 | Problems found, fixed voluntarily | Drug Quality Assurance | 4 |
| Jul 2, 2021 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jul 2, 2021 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jun 20, 2018 | No problems found | Drug Quality Assurance | — |
| Jun 20, 2018 | No problems found | Drug Quality Assurance | — |
| Dec 3, 2015 | No problems found | Drug Quality Assurance | — |
| Dec 3, 2015 | No problems found | Drug Quality Assurance | — |
| Nov 24, 2014 | Problems found, fixed voluntarily | Drug Quality Assurance | 8 |
| Nov 24, 2014 | Problems found, fixed voluntarily | Drug Quality Assurance | 8 |
| Aug 28, 2013 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Aug 28, 2013 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
What inspectors wrote down
From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.
Nov 4, 2025 inspection
- Validation lacking for sterile drug products 21 CFR 211.113(b)
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include adequate validation of the aseptic process. - Validation lacking for sterile drug products 21 CFR 211.113(b)
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include adequate validation of the aseptic process. - Procedures not in writing, fully followed 21 CFR 211.22(d)
The responsibilities and procedures applicable to the quality control unit are not in writing. - Procedures not in writing, fully followed 21 CFR 211.22(d)
The responsibilities and procedures applicable to the quality control unit are not in writing.
Nov 24, 2014 inspection
- Procedures for sterile drug products 21 CFR 211.113(b)
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established. - Procedures for sterile drug products 21 CFR 211.113(b)
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established. - Procedures not in writing, fully followed 21 CFR 211.22(d)
The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed. - Procedures not in writing, fully followed 21 CFR 211.22(d)
The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed. - Training , Education , Experience overall 21 CFR 211.25(a)
Employees engaged in the processing of a drug product lack the training and experience required to perform their assigned functions. - Training , Education , Experience overall 21 CFR 211.25(a)
Employees engaged in the processing of a drug product lack the training and experience required to perform their assigned functions. - Equipment Design, Size and Location 21 CFR 211.63
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design to facilitate operations for its intended use. - Equipment Design, Size and Location 21 CFR 211.63
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design to facilitate operations for its intended use.
Registered with FDA for: analysis; manufacture; sterilize.