Overview
- 20 public-safe observations are available for this inspection.
- 10 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.
21 May 2018
21 CFR 111.103
Written procedures - quality control operations
Cited by Matthew A Johnson, Jennifer Guttuso
21 May 2018
21 CFR 111.103
Written procedures - quality control operations
Cited by Matthew A Johnson, Jennifer Guttuso
21 May 2018
21 CFR 111.105(a)
Processes, specifications, written procedures
Cited by Matthew A Johnson, Jennifer Guttuso
21 May 2018
21 CFR 111.105(a)
Processes, specifications, written procedures
Cited by Matthew A Johnson, Jennifer Guttuso
21 May 2018
21 CFR 111.113(a)(2)
QC master manufacturing record; material review, disposition
Cited by Matthew A Johnson, Jennifer Guttuso
Inspected site
DNDesigned Nutritional Products, Inc.Orem, 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 111.105(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.113(a)(2) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.25(c) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.70(b)(1) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.70(b)(2) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.70(b)(3) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.70(d) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.70(e) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.75(a)(1)(i) | Cited across public-safe Form 483 observations | 2x |
Full 483 report
Get the verbatim text of all 20 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