Overview
- 9 public-safe observations are available for this inspection.
- 3 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.
Process Controls Corrective Action Procedures - Content
Cited by Michael A Feingold, Lindsay P Williams, Ron R Pearson
Process Controls Corrective Action Procedures - Content
Cited by Michael A Feingold, Lindsay P Williams, Ron R Pearson
Plant construction and design
Cited by Michael A Feingold, Lindsay P Williams, Ron R Pearson
Plant construction and design
Cited by Michael A Feingold, Lindsay P Williams, Ron R Pearson
RFR - investigate cause
Cited by Michael A Feingold, Lindsay P Williams, Ron R Pearson
Inspected site
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 117.150(a)(2) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 117.20(b) | Cited across public-safe Form 483 observations | 3x |
| FDCA 417(d)(1)(B) | Cited across public-safe Form 483 observations | 3x |
Full 483 report
Get the verbatim text of all 9 observations
The full inspection record, as Atlas holds it, 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