Overview
- 2 public-safe observations are available for this inspection.
- 2 structured CFR citations are represented.
- 3 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
8 Dec 2023
21 CFR 606.171
Biological product deviation report
Cited by Richard T Riggie, Christian Lynch, Nisha C Patel
8 Dec 2023
21 CFR 820.50(a)(1)
Evaluation and Selection, Suppliers, Contractors, etc.
Cited by Richard T Riggie, Christian Lynch, Nisha C Patel
Inspected site
RMRoche Molecular Systems, Inc.Branchburg, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 606.171 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.50(a)(1) | 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 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