Overview
- 2 public-safe observations are available for this inspection.
- 2 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.
8 Nov 2012
21 CFR 211.188
Prepared for each batch, include complete information
Cited by Mark E Chan, Caryn M Mcnab
8 Nov 2012
21 CFR 211.188(b)(7)
Actual yield, % of theoretical yield
Cited by Mark E Chan, Caryn M Mcnab
Inspected site
NPNova Pneuma, Inc.Fremont, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.188 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.188(b)(7) | 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 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