Overview
- 4 public-safe observations are available for this inspection.
- 4 structured CFR citations are represented.
- 4 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
30 Jul 2025
21 CFR 117.130(a)(1)
Hazard analysis - Identification of hazard
Cited by Eric R Holm, Oluwaseyi Ojinni, Solomon G Williams, Aryonna M Renouf
30 Jul 2025
21 CFR 117.135(c)(2)
Allergen preventive controls - Appropriate (Adequate)
Cited by Eric R Holm, Oluwaseyi Ojinni, Solomon G Williams, Aryonna M Renouf
30 Jul 2025
21 CFR 117.35(c)
Pest control
Cited by Eric R Holm, Oluwaseyi Ojinni, Solomon G Williams, Aryonna M Renouf
30 Jul 2025
21 CFR 117.405(a)(1)
Supply-chain program - Implement
Cited by Eric R Holm, Oluwaseyi Ojinni, Solomon G Williams, Aryonna M Renouf
Inspected site
NZNg Zheng IncDenver, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 117.130(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 117.35(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 117.405(a)(1) | Cited across public-safe Form 483 observations | 1x |
Source document
PDF
PDF available
Form 483 source document
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Full 483 report
Get the verbatim text of all 4 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