Overview
- 9 public-safe observations are available for this inspection.
- 8 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.
2 Jul 2021
21 CFR 211.160(a)
Deviations from laboratory control requirements
Cited by Ivis L Negron Torres, Marian E Ramirez
2 Jul 2021
21 CFR 211.160(a)
Following/documenting laboratory controls
Cited by Ivis L Negron Torres, Marian E Ramirez
2 Jul 2021
21 CFR 211.160(b)(4)
Written calibration procedures
Cited by Ivis L Negron Torres, Marian E Ramirez
2 Jul 2021
21 CFR 211.166(a)
Written program not followed
Cited by Ivis L Negron Torres, Marian E Ramirez
2 Jul 2021
21 CFR 211.166(a)(4)
Testing in same container - closure system
Cited by Ivis L Negron Torres, 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 211.160(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.160(b)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(a)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.180(e)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.58 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(b)(6) | Cited across public-safe Form 483 observations | 1x |
Source document
PDF
PDF available
Form 483 source document
The source document is available to authorized Atlas users.
Full 483 report
Get the verbatim text of all 9 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