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.
4 Aug 2011
21 CFR 211.22(a)
Authority lacking to review records, investigate errors
Cited by Debra I Love, Denarvis C Mendenhall
4 Aug 2011
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Debra I Love, Denarvis C Mendenhall
4 Aug 2011
21 CFR 211.142(a)
Quarantine - written procedures
Cited by Debra I Love, Denarvis C Mendenhall
Inspected site
RPRespa Pharmaceuticals Inc.Addison, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.142(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.150 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 5 observations
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