Overview
- 5 public-safe observations are available for this inspection.
- 5 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.
20 Mar 2020
21 CFR 111.105(i)
QC - required operations master manufacturing/batch records
Cited by Matthew A Johnson, Richard T Jensen, Brandon K Lawson
20 Mar 2020
21 CFR 111.205(a)
Master manufacturing record - each batch
Cited by Matthew A Johnson, Richard T Jensen, Brandon K Lawson
20 Mar 2020
21 CFR 111.205(c)
Master manufacturing record: electronic
Cited by Matthew A Johnson, Richard T Jensen, Brandon K Lawson
20 Mar 2020
21 CFR 117.130(a)(1)
Hazard Analysis - Identification of Hazard
Cited by Matthew A Johnson, Richard T Jensen, Brandon K Lawson
20 Mar 2020
21 CFR 117.145(a)
Process Controls Monitoring Procedures: Establish Implement
Cited by Matthew A Johnson, Richard T Jensen, Brandon K Lawson
Inspected site
CNCSB Nutrition CorporationSpanish Fork, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 111.105(i) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.205(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.205(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 117.130(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 117.145(a) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 5 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