Overview
- 21 public-safe observations are available for this inspection.
- 7 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.
2 Aug 2018
21 CFR 803.50(a)(1)
Report of Death or Serious Injury
Cited by Stephen C Smith, Eric C Schmitt, Diane M Biron
2 Aug 2018
21 CFR 803.50(a)(2)
Report of Malfunction
Cited by Stephen C Smith, Eric C Schmitt, Diane M Biron
2 Aug 2018
21 CFR 820.70(c)
Environmental control Lack of or inadequate procedures
Cited by Stephen C Smith, Eric C Schmitt, Diane M Biron
Inspected site
AMAtrium Medical CorporationMerrimack, United States
Inspection team
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 | 3x |
| 21 CFR 803.50(a)(2) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.100(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.70(c) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.70(e) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.72(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.75(a) | Cited across public-safe Form 483 observations | 3x |
Full 483 report
Get the verbatim text of all 21 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