Overview
- 16 public-safe observations are available for this inspection.
- 14 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.
22 Oct 2012
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Ivis L Negron Torres, Edwin Martinez, Jose R Lopez
22 Oct 2012
21 CFR 211.63
Equipment Design, Size and Location
Cited by Ivis L Negron Torres, Edwin Martinez, Jose R Lopez
22 Oct 2012
21 CFR 211.67(a)
Cleaning / Sanitizing / Maintenance
Cited by Ivis L Negron Torres, Edwin Martinez, Jose R Lopez
22 Oct 2012
21 CFR 211.67(b)
Written procedures not established/followed
Cited by Ivis L Negron Torres, Edwin Martinez, Jose R Lopez
22 Oct 2012
21 CFR 211.68(b)
Backup data not assured as exact and complete
Cited by Ivis L Negron Torres, Edwin Martinez, Jose R Lopez
Inspected site
CHCaribe Holdings (Cayman) Co. Ltd dba PuraCap CaribeDorado, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.160(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.170(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a)(4) | 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 211.63 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 16 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