Grand River Aseptic Manufacturing, Inc.
Form 483 issued September 19, 2024 · Grand Rapids, Michigan
- Inspection
- Sep 19, 2024
- Investigators
- Neetu Dahiya· Wei Wang
- Observations
- 2
- Pages
- 2
- FEI number
- 3008716173
In short: On September 19, 2024, FDA issued a Form 483 with 2 observations to Grand River Aseptic Manufacturing, Inc. in Grand Rapids, Michigan (FEI 3008716173) after an inspection that ran Sep 19, 2024. The investigators were Neetu Dahiya and Wei Wang. Most observations concern production; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
2 of 2 observations on this 483 concern production.
Most cited: 21 CFR 211.113 (1×) · 211.188 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The - fill validation study that was performed on the syringe filling line 3 did not…
- 02
Observation 2: scanned text, readable in the full document.
This inspection in context
Neetu Dahiya
1 document · 2024
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Michigan.
The firmGrand River Aseptic Manufacturing, Inc. history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.113
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Grand River Aseptic Manufacturing, Inc.?
FDA listed 2 observations on this Form 483, mostly about production. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
Who inspected Grand River Aseptic Manufacturing, Inc.?
Neetu Dahiya and Wei Wang are named on this Form 483, for the inspection of Sep 19, 2024. Each investigator has a profile showing what they cite most.
When was Grand River Aseptic Manufacturing, Inc. inspected by FDA?
The inspection ran Sep 19, 2024, and the Form 483 is dated September 19, 2024.
How do I get the full Form 483 for Grand River Aseptic Manufacturing, Inc.?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.