Overview
- 8 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.
27 Sep 2023
21 CFR 1.504(b)(1)
Hazard analysis biological, chemical, physical
Cited by Jeannie Pradyanata, Sherry G Gonzalez
27 Sep 2023
21 CFR 1.504(d)
Document review entity's hazard analysis
Cited by Jeannie Pradyanata, Sherry G Gonzalez
27 Sep 2023
21 CFR 1.505(a)(2)
Evaluation - performance, risk
Cited by Jeannie Pradyanata, Sherry G Gonzalez
27 Sep 2023
21 CFR 1.506(a)(1)
Approved supplier procedures - importer established
Cited by Jeannie Pradyanata, Sherry G Gonzalez
Inspected site
PEPurvi Enterprises IncSanta Fe Springs, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 1.504(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1.504(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1.504(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1.505(a)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1.506(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1.506(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1.506(d)(1)(i) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1.506(d)(2) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 8 observations
The full inspection record, as Atlas holds it, 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