Overview
- 8 public-safe observations are available for this inspection.
- 8 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.
1 Aug 2011
21 CFR 111.12(b)
Personnel - quality control operations
Cited by Ashley B Jelonek, Ashley Segura
1 Aug 2011
21 CFR 111.127
Quality control operations - packaging, labeling
Cited by Ashley B Jelonek, Ashley Segura
1 Aug 2011
21 CFR 111.130
Quality control operations - returned dietary supplement
Cited by Ashley B Jelonek, Ashley Segura
1 Aug 2011
21 CFR 111.135
Quality control operations - product complaints
Cited by Ashley B Jelonek, Ashley Segura
Inspected site
XMXymogen Manufacturing, LLCOrlando, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 111.12(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.127 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.130 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.135 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.14(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.410(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.455(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.475(b)(1) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 8 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