Overview
- 3 public-safe observations are available for this inspection.
- 3 structured CFR citations are represented.
- 5 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
17 Jun 2025
21 CFR 106.30(b)
Equipment, utensil - clean, sanitize
Cited by Elizabeth P Mayer, Gerard D Difiore, Alysia M Salonia, Nasser Yazdani, Affiong Flores
17 Jun 2025
21 CFR 106.30(e)(2)(ii)
Cold storage, in-process and final formula - 45 degrees F
Cited by Elizabeth P Mayer, Gerard D Difiore, Alysia M Salonia, Nasser Yazdani, Affiong Flores
17 Jun 2025
21 CFR 106.91(b)(2)
Packaged finished formula - test for nutrients
Cited by Elizabeth P Mayer, Gerard D Difiore, Alysia M Salonia, Nasser Yazdani, Affiong Flores
Inspected site
PNPBM Nutritionals, LLCFairfax, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 106.30(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 106.30(e)(2)(ii) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 106.91(b)(2) | 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 3 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