Overview
- 6 public-safe observations are available for this inspection.
- 2 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.
6 Apr 2017
21 CFR 111.70(e)
Specifications - identity, purity, strength, composition
Cited by Dana M Lewis
6 Apr 2017
21 CFR 111.75(c)(2)
Specifications met - test, examinations; compliance
Cited by Dana M Lewis
6 Apr 2017
21 CFR 111.70(e)
Specifications - identity, purity, strength, composition
Cited by Dana M Lewis
6 Apr 2017
21 CFR 111.70(e)
Specifications - identity, purity, strength, composition
Cited by Dana M Lewis
6 Apr 2017
21 CFR 111.75(c)(2)
Specifications met - test, examinations; compliance
Cited by Dana M Lewis
Inspected site
TETrace Elements, IncAddison, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 111.70(e) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 111.75(c)(2) | Cited across public-safe Form 483 observations | 3x |
Full 483 report
Get the verbatim text of all 6 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