Corium Innovations, Inc.
Form 483 issued October 27, 2017 · Grand Rapids, Michigan
- Inspection
- Oct 23 – Oct 27, 2017
- Investigator
- Charles L. Zhou
- Observations
- 3
- Pages
- 4
- FEI number
- 3003693105
In short: On October 27, 2017, FDA issued a Form 483 with 3 observations to Corium Innovations, Inc. in Grand Rapids, Michigan (FEI 3003693105) after an inspection that ran Oct 23 – Oct 27, 2017. The investigator was Charles L. Zhou. Most observations concern quality system and laboratory controls.
At a glance
Quality system and laboratory controls account for 2 of 3 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 02
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications and test procedures…
- 03
Control procedures are not established which validate the performance of those manufacturing processes that may be…
This inspection in context
Charles L. Zhou
11 documents · 2016–2021
Cites 211.42 (design and construction features) 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 211.192
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 quality system, laboratory controls and production. The opening words of each observation are shown on this page.
Who inspected Corium Innovations, Inc.?
Charles L. Zhou is named on this Form 483, for the inspection of Oct 23 – Oct 27, 2017. Each investigator has a profile showing what they cite most.
When was Corium Innovations, Inc. inspected by FDA?
The inspection ran Oct 23 – Oct 27, 2017, and the Form 483 is dated October 27, 2017.
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.