Overview
- 9 public-safe observations are available for this inspection.
- 9 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.
21 May 2013
21 CFR 111.20(c)(2)
Physical plant - material review and disposition
Cited by Jeanmaire Hryshko, Ronald P Boyce
21 May 2013
21 CFR 111.55
Production, process controls - implement
Cited by Jeanmaire Hryshko, Ronald P Boyce
21 May 2013
21 CFR 111.65
Quality control - quality, dietary supplement
Cited by Jeanmaire Hryshko, Ronald P Boyce
21 May 2013
21 CFR 111.73
Specifications met - received product identified
Cited by Jeanmaire Hryshko, Ronald P Boyce
21 May 2013
21 CFR 111.127
Quality control operations - packaging, labeling
Cited by Jeanmaire Hryshko, Ronald P Boyce
Inspected site
DRDr. Rath International, Inc.San Jose, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 111.127 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.20(c)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.205(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.255(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.535(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.55 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.553 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.65 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.73 | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 9 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