Overview
- 3 public-safe observations are available for this inspection.
- 3 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.
20 Mar 2026
21 CFR 812.140(a)(2)(i)
Investigator device accountability inadequate
Cited by Dina A Tallman
20 Mar 2026
21 CFR 812.140(a)(2)(iii)
Investigator records of disposition of devices inadequate
Cited by Dina A Tallman
20 Mar 2026
21 CFR 812.140(a)(3)(iii)
Investigator records of exposure to device inadequate
Cited by Dina A Tallman
Inspected site
NJNicolas J. Mouawad, MDBay City, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 812.140(a)(2)(i) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 812.140(a)(2)(iii) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 812.140(a)(3)(iii) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 3 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