Overview
- 5 public-safe observations are available for this inspection.
- 5 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.
11 Feb 2010
21 CFR 1271.160(b)(6)
Deviations--Investigation, documenting, trending
Cited by Gene D Arcy, Andy B Lee
11 Feb 2010
21 CFR 1271.195(c)
Monitoring-microorganisms where appropriate
Cited by Gene D Arcy, Andy B Lee
Inspected site
SIStemCyte, IncBaldwin Park, United States
Inspection team
ABAndy B Lee
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 1271.160(b)(6) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.180(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.195(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.230(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.47(a) | Cited across public-safe Form 483 observations | 1x |
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 5 observations
The source PDF and 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