Corium Innovations, Inc.
Form 483 issued November 18, 2022 · Grand Rapids, Michigan
- Investigator
- Brent M. Dehaan
- Observations
- 3
- Pages
- 5
- FEI number
- 3003693105
In short: On November 18, 2022, FDA issued a Form 483 with 3 observations to Corium Innovations, Inc. in Grand Rapids, Michigan (FEI 3003693105). The investigator was Brent M. Dehaan. Most observations concern production and quality system.
At a glance
Production and quality system account for 2 of 3 observations.
What FDA observed
Preview: the opening words of each observation- 01
Control procedures are not established which validate the performance of those manufacturing processes that may be…
- 02
The responsibilities and procedures applicable to the quality control unit are not in…
- 03
Written procedures are lacking for the use of cleaning and sanitizing agents designed to prevent the…
This inspection in context
Brent M. Dehaan
4 documents · 2022
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in Michigan.
The firmCorium Innovations, Inc. history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.110(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Corium Innovations, Inc.?
FDA listed 3 observations on this Form 483, mostly about production, quality system and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected Corium Innovations, Inc.?
Brent M. Dehaan is named on this Form 483. Each investigator has a profile showing what they cite most.
When was Corium Innovations, Inc. inspected by FDA?
This Form 483 is dated November 18, 2022.
How do I get the full Form 483 for Corium Innovations, 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.