Overview
- 8 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.
28 Sep 2021
21 CFR 111.103
Written procedures - quality control operations
Cited by Justin A Boyd, Clinton R Vanblaricom
28 Sep 2021
21 CFR 111.110(c)
Quality control operations - tests, examinations; results
Cited by Justin A Boyd, Clinton R Vanblaricom
28 Sep 2021
21 CFR 111.315(a)
Criteria for establishing specifications
Cited by Justin A Boyd, Clinton R Vanblaricom
28 Sep 2021
21 CFR 111.320(a)
Examination, testing; appropriate
Cited by Justin A Boyd, Clinton R Vanblaricom
28 Sep 2021
21 CFR 111.553
Written procedures - product complaint
Cited by Justin A Boyd, Clinton R Vanblaricom
Inspected site
NLNutritional Laboratories International IncMissoula, 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 | 1x |
| 21 CFR 111.110(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.315(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.320(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.553 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.70(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.75(c)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.75(h)(2) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 8 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