Overview
- 3 public-safe observations are available for this inspection.
- 3 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.
15 Feb 2022
21 CFR 117.35(a)
Sanitary operations - Plant sanitation
Cited by Manuel A Moreno, Oluwaseyi Ojinni, Jin M Kim
15 Feb 2022
21 CFR 117.4
Training of employees and records
Cited by Manuel A Moreno, Oluwaseyi Ojinni, Jin M Kim
15 Feb 2022
21 CFR 117.40
Equipment and utensils - Design and maintenance
Cited by Manuel A Moreno, Oluwaseyi Ojinni, Jin M Kim
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 117.35(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 117.4 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 117.40 | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 3 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