Grand River Aseptic Manufacturing, Inc.
Form 483 issued July 2, 2021 · Grand Rapids, Michigan
- Inspection
- Jun 15 – Jul 2, 2021
- Investigators
- Bei Y. He· Charles L. Zhou· Joseph A. Piechocki
- Observations
- 8
- Pages
- 7
- FEI number
- 3008716173
In short: On July 2, 2021, FDA issued a Form 483 with 8 observations to Grand River Aseptic Manufacturing, Inc. in Grand Rapids, Michigan (FEI 3008716173) after an inspection that ran Jun 15 – Jul 2, 2021. The investigators were Bei Y. He, Charles L. Zhou, Joseph A. Piechocki and Lisa R. Hilliard. Most observations concern facilities & equipment and quality system; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).
At a glance
Facilities & equipment and quality system account for 5 of 8 observations.
Most cited: 21 CFR 211.22 (2×) · 211.67 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The quality control unit lacks authority to fully investigate…
- 02
The responsibilities and procedures applicable to the quality control unit…
- 03
Control procedures are not established which monitor the output and validate the performance of those manufacturing…
- 04
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications designed to assure…
This inspection in context
Bei Y. He
14 documents · 2016–2025
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 211.22
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 8 observations on this Form 483, mostly about facilities & equipment, quality system and production. The most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance). The opening words of each observation are shown on this page.
Who inspected Grand River Aseptic Manufacturing, Inc.?
Bei Y. He, Charles L. Zhou, Joseph A. Piechocki and Lisa R. Hilliard are named on this Form 483, for the inspection of Jun 15 – Jul 2, 2021. Each investigator has a profile showing what they cite most.
When was Grand River Aseptic Manufacturing, Inc. inspected by FDA?
The inspection ran Jun 15 – Jul 2, 2021, and the Form 483 is dated July 2, 2021.
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.