Overview
- 9 public-safe observations are available for this inspection.
- 7 structured CFR citations are represented.
- 2 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
26 Mar 2009
21 CFR 211.84(e)
Rejecting When Specifications Not Met
Cited by Martha Sullivan Myrick, Adam J Wilson
26 Mar 2009
21 CFR 211.110(a)
Control procedures to monitor and validate performance
Cited by Martha Sullivan Myrick, Adam J Wilson
26 Mar 2009
21 CFR 211.110(b)
In-process materials specifications
Cited by Martha Sullivan Myrick, Adam J Wilson
26 Mar 2009
21 CFR 211.186(b)(9)
Manufacturing Instructions and Specifications
Cited by Martha Sullivan Myrick, Adam J Wilson
26 Mar 2009
21 CFR 211.188
Prepared for each batch, include complete information
Cited by Martha Sullivan Myrick, Adam J Wilson
Inspected site
CICorium Innovations, Inc.Grand Rapids, United States
Inspection team
MSMartha Sullivan Myrick
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.194(a)(2) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.110(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.186(b)(9) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.188 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(e) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 9 observations
Every observation in full, so your team sees exactly what was cited and how it was answered.
- The site's full inspection history around this Form 483
- Whether these citations escalated to a warning letter
- The investigators involved and the citations they repeat elsewhere