Overview
- 15 public-safe observations are available for this inspection.
- 5 structured CFR citations are represented.
- 1 investigator is tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
6 Sep 2016
21 CFR 111.153
Written procedures - product received; packaging, labeling
Cited by Karl D Hezel
6 Sep 2016
21 CFR 111.570(b)(1)
Written procedures - product complaint; review, investigate
Cited by Karl D Hezel
6 Sep 2016
21 CFR 111.570(b)(1)
Written procedures - product complaint; review, investigate
Cited by Karl D Hezel
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 111.153 | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 111.570(b)(1) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 111.70(b)(1) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 111.75(a)(2)(ii)(E) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 111.75(c) | Cited across public-safe Form 483 observations | 3x |
Full 483 report
Get the verbatim text of all 15 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