Overview
- 10 public-safe observations are available for this inspection.
- 10 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.
23 Jun 2017
21 CFR 111.12
Personnel - quality control personnel - qualified
Cited by Lissette Paiz, Alexander B Anderson, Jorge L Lajara
23 Jun 2017
21 CFR 111.20(b)
Physical plant - space; equipment, materials
Cited by Lissette Paiz, Alexander B Anderson, Jorge L Lajara
23 Jun 2017
21 CFR 111.20(d)(1)(i)
Floors, walls, ceilings
Cited by Lissette Paiz, Alexander B Anderson, Jorge L Lajara
23 Jun 2017
21 CFR 111.20(d)(1)(iv)
Physical plant - temperature, humidity controls
Cited by Lissette Paiz, Alexander B Anderson, Jorge L Lajara
23 Jun 2017
21 CFR 111.20(f)
Physical plant - bulbs, fixtures, skylights
Cited by Lissette Paiz, Alexander B Anderson, Jorge L Lajara
Inspected site
PSPure Source, LLCDoral, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 111.12 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.20(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.20(d)(1)(i) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.20(d)(1)(iv) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.20(f) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.27(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.70(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.70(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.75(a)(2)(ii)(A) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.75(c) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 10 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