Overview
- 9 public-safe observations are available for this inspection.
- 9 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 May 2013
21 CFR 111.10(b)
Personnel - hygienic practices
Cited by Jessica L Pressley, Ashley A Mutawakkil
24 May 2013
21 CFR 111.27(a)
Equipment - design - suitable
Cited by Jessica L Pressley, Ashley A Mutawakkil
24 May 2013
21 CFR 111.27(d)
Equipment - maintain, clean, sanitize
Cited by Jessica L Pressley, Ashley A Mutawakkil
24 May 2013
21 CFR 111.75(c)
Specifications met - verify; finished batch
Cited by Jessica L Pressley, Ashley A Mutawakkil
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 111.10(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.13(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.27(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.27(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.365(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.455(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.570(b)(2)(ii)(F) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.75(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.75(h)(2) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 9 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