Overview
- 9 public-safe observations are available for this inspection.
- 9 structured CFR citations are represented.
- 2 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
18 Dec 2009
21 CFR 820.20(c)
Management review accomplishment
Cited by Charles D Brown, Tracy J Washington
18 Dec 2009
21 CFR 820.90(a)
Specific non-conforming product procedures
Cited by Charles D Brown, Tracy J Washington
18 Dec 2009
21 CFR 820.181
DMR - not or inadequately maintained
Cited by Charles D Brown, Tracy J Washington
18 Dec 2009
21 CFR 820.181(c)
DMR QA procedures and specifications
Cited by Charles D Brown, Tracy J Washington
Inspected site
EPElectromedical Products International, Inc.Mineral Wells, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.181 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.181(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.184 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.198(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.198(e)(5) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.198(f) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.20(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.90(a) | 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 9 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