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.
3 Sep 2021
21 CFR 111.180(b)(3)
Documentation - components
Cited by Grant L Davis, Sara A Valenzuela, Jacey Roy
3 Sep 2021
21 CFR 111.30(c)
Equipment - automated - calibrate, inspect
Cited by Grant L Davis, Sara A Valenzuela, Jacey Roy
3 Sep 2021
21 CFR 111.455(c)
Hold - mix-up, contamination, deterioration
Cited by Grant L Davis, Sara A Valenzuela, Jacey Roy
Inspected site
LNLaCore Nutraceuticals, Inc.Van Alstyne, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 111.180(b)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.30(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.455(c) | 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