Overview
- 4 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.
9 Jan 2012
21 CFR 803.17(a)(2)
Lack of System for Determining MDR Events
Cited by Sergio Chavez, David Dar
9 Jan 2012
21 CFR 806.10(a)(2)
Report of violation of the Act (see 803.52(e)(9))
Cited by Sergio Chavez, David Dar
9 Jan 2012
21 CFR 820.75(c)
Process changes - review, evaluation and revalidation
Cited by Sergio Chavez, David Dar
Inspected site
CCCelera CorporationWalnut Creek, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 803.17(a)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 806.10(a)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.180 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.75(c) | 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 4 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