Overview
- 2 public-safe observations are available for this inspection.
- 2 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 Sep 2015
21 CFR 58.29(b)
Personnel: summary of training, job description
Cited by Vickie J Kanion, Lisa D Ellis
1 Sep 2015
21 CFR 58.31(f)
Management: personnel understand their functions
Cited by Vickie J Kanion, Lisa D Ellis
Inspected site
XLXenometrics, LLCStilwell, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 58.29(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 58.31(f) | Cited across public-safe Form 483 observations | 1x |
Source document
PDF
PDF available
Form 483 source document
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Full 483 report
Get the verbatim text of all 2 observations
The source PDF, 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