Overview
- 4 public-safe observations are available for this inspection.
- 4 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.
8 Mar 2024
21 CFR 117.135(a)(1)
Preventive controls - Implement (Limited Scope only)
Cited by Jose Perez-Soto, Karl D Hezel
8 Mar 2024
21 CFR 117.135(c)(2)
Allergen preventive controls - Appropriate (Adequate)
Cited by Jose Perez-Soto, Karl D Hezel
8 Mar 2024
21 CFR 117.135(c)(3)
Sanitation preventive controls - Appropriate (Adequate)
Cited by Jose Perez-Soto, Karl D Hezel
8 Mar 2024
21 CFR 117.405(a)(1)
Supply-chain program - Implement
Cited by Jose Perez-Soto, Karl D Hezel
Inspected site
PPPan Pepin, Inc.Bayamon, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 117.135(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 117.135(c)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 117.135(c)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 117.405(a)(1) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 4 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