Overview
- 14 public-safe observations are available for this inspection.
- 14 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.
26 Feb 2016
21 CFR 111.210(c)
Master manufacturing record - components; weight, measure
Cited by Kevin A Beavers, Tara M Aikens, Tara M Humfeld
26 Feb 2016
21 CFR 111.365(a)
Conditions, controls -protect; microorganisms, contamination
Cited by Kevin A Beavers, Tara M Aikens, Tara M Humfeld
26 Feb 2016
21 CFR 111.453
Written procedures - holding
Cited by Kevin A Beavers, Tara M Aikens, Tara M Humfeld
26 Feb 2016
21 CFR 111.465(a)(2)
Hold - reserve sample; closure system- packaged, labeled
Cited by Kevin A Beavers, Tara M Aikens, Tara M Humfeld
26 Feb 2016
21 CFR 111.70(b)(1)
Specifications - component identity
Cited by Kevin A Beavers, Tara M Aikens, Tara M Humfeld
Inspected site
JNJT Naturals, LLC.Joplin, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 111.113(a)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.123(a)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.13(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.205(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.210(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.260(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.365(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.365(i) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.453 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.460(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.465(a)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.70(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.75(a)(2)(ii)(A) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.75(c) | Cited across public-safe Form 483 observations | 1x |
Source document
PDF
PDF available
Form 483 source document
The source document is available to authorized Atlas users.
Full 483 report
Get the verbatim text of all 14 observations
The source PDF and 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