Grand River Aseptic Manufacturing, Inc.
FDA inspection history in Grand Rapids, Michigan, 2021 to 2024
- 2
- Form 483s
Every document, by year
- Form 483
2021: one Form 483; 2024: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2021One Form 483, at Grand Rapids, Michigan.
- 2021The longest 483 on file: 8 observations over 7 pages at Grand Rapids, Michigan.
- 2024One Form 483, at Grand Rapids, Michigan.
Cited most
Across all Grand River Aseptic Manufacturing observations on file
- 21 CFR 211.22Responsibilities of quality control unit2
- 21 CFR 211.67Equipment cleaning and maintenance2
- 21 CFR 211.110Sampling and testing of in-process materials and drug products1
- 21 CFR 211.113Control of microbiological contamination1
- 21 CFR 211.160General requirements1
The complete Grand River Aseptic Manufacturing file.
All 2 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Grand Rapids, Michigan
Two Form 483s · 2021 to 2024 · 10 observations
Latest: Form 483, Sep 19, 2024 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2024-09-19 | 483 Form 483 | Grand Rapids, Michigan | 2 | $99 |
| 2021-07-02 | 483 Form 483 | Grand Rapids, Michigan | 8 | $99 |
Investigators on these documents
Bei Y. He (1)Charles L. Zhou (1)Joseph A. Piechocki (1)Lisa R. Hilliard (1)Neetu Dahiya (1)Wei Wang (1)
FEI number 3008716173 · most recent document Sep 19, 2024
About Grand River Aseptic Manufacturing, Inc.
How many FDA Form 483s has Grand River Aseptic Manufacturing, Inc. received?
FDA Intel has 2 Form 483s on file for Grand River Aseptic Manufacturing, Inc.; the most recent is dated Sep 19, 2024.
When was Grand River Aseptic Manufacturing, Inc. last inspected by FDA?
The most recent FDA inspection document on file for Grand River Aseptic Manufacturing, Inc. is a Form 483 dated Sep 19, 2024, for the site in Grand Rapids, Michigan.
What did FDA cite at Grand River Aseptic Manufacturing, Inc.?
The regulations cited most in the observations on file for Grand River Aseptic Manufacturing, Inc. are 21 CFR 211.22 (Responsibilities of quality control unit), 2 times; 21 CFR 211.67 (Equipment cleaning and maintenance), 2 times; 21 CFR 211.110 (Sampling and testing of in-process materials and drug products), 1 time.