Overview
- 10 public-safe observations are available for this inspection.
- 10 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.
19 Nov 2012
21 CFR 111.70(b)(2)
Specifications-component purity, strength, composition
Cited by Jamie M Bumpas, Daniel S Fam, Cathleen A Castellaw
19 Nov 2012
21 CFR 111.70(e)
Specifications - identity, purity, strength, composition
Cited by Jamie M Bumpas, Daniel S Fam, Cathleen A Castellaw
19 Nov 2012
21 CFR 111.75(a)(1)(i)
Component - verify identity, dietary ingredient
Cited by Jamie M Bumpas, Daniel S Fam, Cathleen A Castellaw
19 Nov 2012
21 CFR 111.160(d)(1)
Packaging - identify
Cited by Jamie M Bumpas, Daniel S Fam, Cathleen A Castellaw
19 Nov 2012
21 CFR 111.205(a)
Master manufacturing record - each batch
Cited by Jamie M Bumpas, Daniel S Fam, Cathleen A Castellaw
Inspected site
NTNATURAL TECHNOLOGY, LLCTerrell, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 111.160(d)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.205(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.210(f) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.210(g) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.260(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.260(g) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.260(l)(1)(ii) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.70(b)(2) | 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(a)(1)(i) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 10 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