Overview
- 7 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.
5 Jun 2013
21 CFR 111.12(c)
Personnel - education, training, experience
Cited by Rachel Gomez, John J Bernal
5 Jun 2013
21 CFR 111.65
Quality control - quality, dietary supplement
Cited by Rachel Gomez, John J Bernal
5 Jun 2013
21 CFR 111.70(a)
Specifications - manufacturing process
Cited by Rachel Gomez, John J Bernal
5 Jun 2013
21 CFR 111.75(c)
Specifications met - verify; finished batch
Cited by Rachel Gomez, John J Bernal
Inspected site
XLXtra Life Natural ProductsHialeah, 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 111.205(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.255(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.30(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.65 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.70(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.75(c) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 7 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