Overview
- 10 public-safe observations are available for this inspection.
- 10 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.
17 Aug 2012
21 CFR 803.50(a)(1)
Report of Death or Serious Injury
Cited by Stanley B Eugene, Ashleigh P Barkans
17 Aug 2012
21 CFR 820.20(b)
Lack of or inadequate organizational structure
Cited by Stanley B Eugene, Ashleigh P Barkans
17 Aug 2012
21 CFR 820.20(c)
Management review - defined interval, sufficient frequency
Cited by Stanley B Eugene, Ashleigh P Barkans
17 Aug 2012
21 CFR 820.30(i)
Design changes - Lack of or Inadequate Procedures
Cited by Stanley B Eugene, Ashleigh P Barkans
17 Aug 2012
21 CFR 820.40
Lack of procedures, or not maintained
Cited by Stanley B Eugene, Ashleigh P Barkans
Inspected site
PMParks Medical Electronics, IncAloha, United States
Inspection team
APAshleigh P Barkans
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 803.50(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.184 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.20(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.20(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.200(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(i) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.40 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.50 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.50(a)(2) | 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 10 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