Overview
- 9 public-safe observations are available for this inspection.
- 9 structured CFR citations are represented.
- 1 investigator is tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
25 Apr 2017
21 CFR 111.105(i)
QC - required operations master manufacturing/batch records
Cited by Elodie X Tong-Lin
25 Apr 2017
21 CFR 111.535(a)
Records - returned dietary supplement: readily available
Cited by Elodie X Tong-Lin
25 Apr 2017
21 CFR 111.70(b)(2)
Specifications-component purity, strength, composition
Cited by Elodie X Tong-Lin
25 Apr 2017
21 CFR 111.77(a)
Specifications not met - reject, quality control
Cited by Elodie X Tong-Lin
Inspected site
TEThreshold Enterprises, Ltd.Scotts Valley, 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 111.320(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.475(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.503 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.535(a) | 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(c)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.70(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.77(a) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 9 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