Grand River Aseptic Manufacturing Inc.
Form 483 issued September 29, 2023 · Caledonia Township, Michigan
- Observations
- 1
- Pages
- 3
- FEI number
- 3019594046
In short: On September 29, 2023, FDA issued a Form 483 with 1 observation to Grand River Aseptic Manufacturing Inc. in Caledonia Township, Michigan (FEI 3019594046). Most observations concern production; the most-cited regulation is 21 CFR 211.110 (sampling and testing of in-process materials and drug products).
At a glance
1 of 1 observations on this 483 concern production.
Most cited: 21 CFR 211.110 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Control procedures are not established which monitor the output and validate the performance of those manufacturing…
This inspection in context
Questions about this 483
What did FDA find at Grand River Aseptic Manufacturing Inc.?
FDA listed 1 observation on this Form 483, mostly about production. The most-cited regulation is 21 CFR 211.110 (sampling and testing of in-process materials and drug products). The opening words of each observation are shown on this page.
When was Grand River Aseptic Manufacturing Inc. inspected by FDA?
This Form 483 is dated September 29, 2023.
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.