Overview
- 12 public-safe observations are available for this inspection.
- 6 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.
15 Jun 2017
21 CFR 111.140(b)(1)
Records - quality control operations; responsibilities
Cited by Nancy E Byerly
15 Jun 2017
21 CFR 111.140(b)(1)
Records - quality control operations; responsibilities
Cited by Nancy E Byerly
15 Jun 2017
21 CFR 111.475(a)
Records - holding, distribution: readily available
Cited by Nancy E Byerly
Inspected site
EPEsteem Products LTDDuvall, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 111.140(b)(1) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.180(b)(1) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.475(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.475(b)(1) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.570(b)(1) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.70(f) | Cited across public-safe Form 483 observations | 2x |
Full 483 report
Get the verbatim text of all 12 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