Overview
- 8 public-safe observations are available for this inspection.
- 4 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.
15 Jul 2016
21 CFR 58.185(a)(10)
Final report: names of those involved
Cited by Carmen Y Fisher, Abhijit Raha
15 Jul 2016
21 CFR 58.190(a)
Archives: data, documentation, specimens
Cited by Carmen Y Fisher, Abhijit Raha
15 Jul 2016
21 CFR 58.31(f)
Management: personnel understand their functions
Cited by Carmen Y Fisher, Abhijit Raha
15 Jul 2016
21 CFR 58.185(a)(10)
Final report: names of those involved
Cited by Carmen Y Fisher, Abhijit Raha
Inspected site
XLXenometrics, LLCStilwell, United States
Inspection team
ARAbhijit Raha
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 58.185(a)(10) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 58.190(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 58.31(f) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 58.81(a) | Cited across public-safe Form 483 observations | 2x |
Source document
PDF
PDF available
Form 483 source document
The source document is available to authorized Atlas users.
Full 483 report
Get the verbatim text of all 8 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