Overview
- 14 public-safe observations are available for this inspection.
- 9 structured CFR citations are represented.
- 3 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
11 Jul 2024
21 CFR 803.50(a)(1)
Report of Death or Serious Injury
Cited by Melissa A Zuppe, Colin E Tack, Monica L Gutierrez
11 Jul 2024
21 CFR 803.50(a)(2)
Individual Report of Malfunction
Cited by Melissa A Zuppe, Colin E Tack, Monica L Gutierrez
11 Jul 2024
21 CFR 803.56
Submission of Supplement to Individual Report Within One Month
Cited by Melissa A Zuppe, Colin E Tack, Monica L Gutierrez
11 Jul 2024
21 CFR 820.100(a)
Lack of or inadequate procedures
Cited by Melissa A Zuppe, Colin E Tack, Monica L Gutierrez
11 Jul 2024
21 CFR 820.198(a)
Lack of or inadequate complaint procedures
Cited by Melissa A Zuppe, Colin E Tack, Monica L Gutierrez
Inspected site
MCMaquet Cardiovascular, LLCWayne, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.30(g) | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 803.50(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 803.50(a)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 803.56 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.198(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.50 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.80(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.90(a) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 14 observations
The full inspection record, as Atlas holds it, 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