Drug factory · FDA FEI 3019594046

Grand River Aseptic Manufacturing Inc.

6670 Patterson Ave. SE Suite 1A, Caledonia Township, 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.

1 drug inspection on record since 2025: 0 with no problems, 1 with problems fixed voluntarily, 0 with FDA action.

What it does, for whom

Drug	Role	For	NDC
Chikungunya Virus Senegal Strain 37997 Capsid Protein and Chikungunya Virus Senegal Strain 37997 Envelope Protein E1 and Chikungunya Virus Senegal Strain 37997 Envelope Protein E2	Tests it	Bavarian Nordic A/S	50632-018

Ended	Result	Program	Problems noted
Nov 4, 2025	Problems found, fixed voluntarily	Drug Quality Assurance	2

From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.

Control procedures to monitor and validate performance 21 CFR 211.110(a)
Control procedures are not established which monitor the output and validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product.
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.

Registered with FDA for: analysis; label; manufacture; pack; sterilize.