Overview
- 14 public-safe observations are available for this inspection.
- 14 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 Dec 2017
21 CFR 111.153
Written procedures - product received; packaging, labeling
Cited by John J Bernal, Sharon Giamberini
4 Dec 2017
21 CFR 111.205(b)(2)
Master manufacturing record - controls, procedures
Cited by John J Bernal, Sharon Giamberini
4 Dec 2017
21 CFR 111.410(c)
Packaging, labels - master manufacturing record
Cited by John J Bernal, Sharon Giamberini
4 Dec 2017
21 CFR 111.553
Written procedures - product complaint
Cited by John J Bernal, Sharon Giamberini
Inspected site
RHRAPHA Health Network International, Inc.Doral, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 111.103 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.153 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.205(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.205(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.23(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.25 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.255(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.303 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.353 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.410(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.430(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.475(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.535(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.553 | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 14 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