Corium Innovations, Inc.
Form 483 issued September 20, 2019 · Grand Rapids, Michigan
- Inspection
- Sep 16 – Sep 20, 2019
- Investigator
- Charles L. Zhou
- Observations
- 1
- Pages
- 1
- FEI number
- 3003693105
In short: On September 20, 2019, FDA issued a Form 483 with 1 observation to Corium Innovations, Inc. in Grand Rapids, Michigan (FEI 3003693105) after an inspection that ran Sep 16 – Sep 20, 2019. The investigator was Charles L. Zhou. Most observations concern quality system; the most-cited regulation is 21 CFR 211.198 (complaint files).
At a glance
1 of 1 observations on this 483 concern quality system.
Most cited: 21 CFR 211.198 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures describing the handling of written and oral complaints related to drug products are…
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 211.198
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Corium Innovations, Inc.?
FDA listed 1 observation on this Form 483, mostly about quality system. The most-cited regulation is 21 CFR 211.198 (complaint files). 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 Sep 16 – Sep 20, 2019. Each investigator has a profile showing what they cite most.
When was Corium Innovations, Inc. inspected by FDA?
The inspection ran Sep 16 – Sep 20, 2019, and the Form 483 is dated September 20, 2019.
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.