Overview
- 7 public-safe observations are available for this inspection.
- 7 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.
10 Mar 2020
21 CFR 211.110(a)
Control procedures to monitor and validate performance
Cited by Ivis L Negron Torres, Jose F Velez, Marian E Ramirez
10 Mar 2020
21 CFR 211.130
Procedures are written, and followed
Cited by Ivis L Negron Torres, Jose F Velez, Marian E Ramirez
10 Mar 2020
21 CFR 211.160(a)
Lab controls established, including changes
Cited by Ivis L Negron Torres, Jose F Velez, Marian E Ramirez
10 Mar 2020
21 CFR 211.166(a)
Written program not followed
Cited by Ivis L Negron Torres, Jose F Velez, Marian E Ramirez
10 Mar 2020
21 CFR 211.194(a)(5)
Testing Calculations
Cited by Ivis L Negron Torres, Jose F Velez, Marian E Ramirez
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 211.110(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.130 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a)(5) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.46(b) | Cited across public-safe Form 483 observations | 1x |
Source document
PDF
PDF available
Form 483 source document
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Full 483 report
Get the verbatim text of all 7 observations
The source PDF, 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