Overview
- 4 public-safe observations are available for this inspection.
- 2 structured CFR citations are represented.
- 3 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
5 Apr 2016
21 CFR 111.325(b)(2)(ii)
Records - document; results
Cited by Gina C Chen, John J Bernal, Karl D Hezel
5 Apr 2016
21 CFR 111.325(b)(2)(ii)
Records - document; results
Cited by Gina C Chen, John J Bernal, Karl D Hezel
5 Apr 2016
21 CFR 111.553
Written procedures - product complaint
Cited by Gina C Chen, John J Bernal, Karl D Hezel
5 Apr 2016
21 CFR 111.553
Written procedures - product complaint
Cited by Gina C Chen, John J Bernal, Karl D Hezel
Inspected site
ISInnova SoftGel LLCMiami, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 111.325(b)(2)(ii) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.553 | Cited across public-safe Form 483 observations | 2x |
Full 483 report
Get the verbatim text of all 4 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