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 May 2010
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Jose A Moreno, Jose R Lopez
4 May 2010
21 CFR 211.65(a)
Equipment construction - reactive surfaces
Cited by Jose A Moreno, Jose R Lopez
4 May 2010
21 CFR 211.67(b)
Written procedures not established/followed
Cited by Jose A Moreno, Jose R Lopez
4 May 2010
21 CFR 211.110(a)
Control procedures to monitor and validate performance
Cited by Jose A Moreno, Jose R Lopez
Inspected site
PPPatheon Puerto Rico Inc.Caguas, United States
Inspection team
JAJose A Moreno
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.198(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.65(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(b) | 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