Dexcom, Inc.
Form 483 issued November 7, 2024 · San Diego, California
- Inspection
- Oct 21 – Nov 7, 2024
- Investigators
- Adam J. Ruben· James R. Montero· Mary A. Millner
- Observations
- 7
- Pages
- 11
- FEI number
- 3004753838
In short: On November 7, 2024, FDA issued a Form 483 with 7 observations to Dexcom, Inc. in San Diego, California (FEI 3004753838) after an inspection that ran Oct 21 – Nov 7, 2024. The investigators were Adam J. Ruben, James R. Montero and Mary A. Millner. Most observations concern design controls and production & process controls; the most-cited regulation is 21 CFR 820.30 (design controls).
At a glance
Design controls and production & process controls account for 6 of 7 observations.
What FDA observed
Preview: the opening words of each observation- 01
Procedures for monitoring and control of process parameters for a validated process have…
- 02
A process whose results cannot be fully verified by subsequent inspection and test has not been…
- 03
Procedures for design input have…
- 04
Procedures for design output have…
This inspection in context
Adam J. Ruben
1 document · 2024
Cites 820.30(c) (design controls) more than any other section. Most of their documents are for sites in California.
The firmDexcom, Inc. history
All 7 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 820.75(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Dexcom, Inc.?
FDA listed 7 observations on this Form 483, mostly about design controls, production & process controls and cAPA. The most-cited regulation is 21 CFR 820.30 (design controls). The opening words of each observation are shown on this page.
Who inspected Dexcom, Inc.?
Adam J. Ruben, James R. Montero and Mary A. Millner are named on this Form 483, for the inspection of Oct 21 – Nov 7, 2024. Each investigator has a profile showing what they cite most.
When was Dexcom, Inc. inspected by FDA?
The inspection ran Oct 21 – Nov 7, 2024, and the Form 483 is dated November 7, 2024.
How do I get the full Form 483 for Dexcom, Inc.?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.