Overview
- 6 public-safe observations are available for this inspection.
- 3 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.
27 May 2016
21 CFR 58.47(a)(3)
Facility: article mixture storage areas
Cited by Stuart W Russell, Abhijit Raha
27 May 2016
21 CFR 58.47(a)(3)
Facility: article mixture storage areas
Cited by Stuart W Russell, Abhijit Raha
Inspected site
SISRI InternationalMenlo Park, United States
Inspection team
ARAbhijit Raha
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 58.190(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 58.47(a)(3) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 58.63(b) | Cited across public-safe Form 483 observations | 2x |
Source document
PDF
PDF available
Form 483 source document
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Full 483 report
Get the verbatim text of all 6 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