Overview
- 5 public-safe observations are available for this inspection.
- 5 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.
10 Jan 2014
21 CFR 111.12(c)
Personnel - education, training, experience
Cited by Omayra N Rodriguez-Ruiz, Rachel Gomez
10 Jan 2014
21 CFR 111.130
Quality control operations - returned dietary supplement
Cited by Omayra N Rodriguez-Ruiz, Rachel Gomez
10 Jan 2014
21 CFR 111.455(c)
Hold - mix-up, contamination, deterioration
Cited by Omayra N Rodriguez-Ruiz, Rachel Gomez
10 Jan 2014
21 CFR 111.535(a)
Records - returned dietary supplement: readily available
Cited by Omayra N Rodriguez-Ruiz, Rachel Gomez
Inspected site
CIClearFreight, Inc.Doral, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 111.12(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.130 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.453 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.455(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.535(a) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 5 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