Overview
- 16 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.
24 Aug 2018
21 CFR 111.103
Written procedures - quality control operations
Cited by Young M Yoon, Kimberly J Proctor Jones
24 Aug 2018
21 CFR 111.205(a)
Master manufacturing record - each batch
Cited by Young M Yoon, Kimberly J Proctor Jones
24 Aug 2018
21 CFR 111.210(h)(1)
Instructions; specifications; quality
Cited by Young M Yoon, Kimberly J Proctor Jones
Inspected site
NINutriResearch IncKent, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 111.103 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.205(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.210(h)(1) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.255(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.403 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.415(c) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.70(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.75(a)(2)(ii)(A) | Cited across public-safe Form 483 observations | 2x |
Full 483 report
Get the verbatim text of all 16 observations
Every observation in full, 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