Overview
- 6 public-safe observations are available for this inspection.
- 6 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.
24 Jun 2016
21 CFR 111.553
Written procedures - product complaint
Cited by Marinee Flores-Marrero, Michael C Lombardi
24 Jun 2016
21 CFR 111.70(b)(1)
Specifications - component identity
Cited by Marinee Flores-Marrero, Michael C Lombardi
24 Jun 2016
21 CFR 111.103
Written procedures - quality control operations
Cited by Marinee Flores-Marrero, Michael C Lombardi
24 Jun 2016
21 CFR 111.205(a)
Master manufacturing record - unique formulation
Cited by Marinee Flores-Marrero, Michael C Lombardi
24 Jun 2016
21 CFR 111.255(a)
Batch record - every batch
Cited by Marinee Flores-Marrero, Michael C Lombardi
Inspected site
CNCaribe Natural LLCMiami, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 111.103 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.205(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.255(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.453 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.553 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.70(b)(1) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 6 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