Overview
- 7 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.
7 Nov 2024
21 CFR 820.100(a)
Lack of or inadequate procedures
Cited by James R Montero, Mary A Millner, Adam J Ruben
7 Nov 2024
21 CFR 820.30(c)
Design input - Lack of or inadequate procedures
Cited by James R Montero, Mary A Millner, Adam J Ruben
7 Nov 2024
21 CFR 820.30(d)
Design output - Lack of or inadequate procedures
Cited by James R Montero, Mary A Millner, Adam J Ruben
7 Nov 2024
21 CFR 820.30(g)
Design Validation - Risk analysis not performed/inadequate
Cited by James R Montero, Mary A Millner, Adam J Ruben
7 Nov 2024
21 CFR 820.30(i)
Design changes - Lack of or Inadequate Procedures
Cited by James R Montero, Mary A Millner, Adam J Ruben
Inspected site
DIDexcom, Inc.San Diego, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(g) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(i) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.75(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.75(b) | 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 7 observations
The source PDF, 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