Dexcom, Inc.
FDA inspection history in San Diego, California, 2010 to 2025
- 3
- Warning letters
- 2
- Close-outs
- 1
- Form 483
- 1
- EIR
Every document, by year
- Warning letter
- Form 483
- Close-out
- EIR
2010: one warning letter and one inspection report; 2014: one warning letter; 2015: two close-out letters; 2024: one Form 483; 2025: one warning letter.
The story so far
Built from the dates and citations on the documents themselves.
- 2010One warning letter and one inspection report, at San Diego, California.
- 2014–15Two close-out letters and one warning letter, at San Diego, California.
- 2024–25One Form 483 and one warning letter, at San Diego, California.
Cited most
Across all Dexcom observations on file
- 21 CFR 820.30(c)Design controls4
- 21 CFR 820.75(a)Process validation2
- 21 CFR 820.100(a)Corrective and preventive action1
The complete Dexcom file.
All 7 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
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Sites
San Diego, California
Three warning letters, two close-out letters, one Form 483 and one inspection report · 2010 to 2025 · 7 observations
Latest: Warning letter, Mar 4, 2025 →
Documents
7 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2025-03-04 | Warning letter Warning letter | San Diego, California | — | $99 |
| 2024-11-07 | 483 Form 483 | San Diego, California | 7 | $99 |
| 2015-05-21 | Close-out Close-out letter | San Diego, California | — | $99 |
| 2015-05-21 | Close-out Close-out letter | San Diego, California | — | $99 |
| 2014-03-14 | Warning letter Warning letter | San Diego, California | — | $99 |
| 2010-05-21 | Warning letter Warning letter | San Diego, California | — | $99 |
| 2010-02-08 | EIR EIR | San Diego, California | — | $550 |
Investigators on these documents
Adam J. Ruben (1)James R. Montero (1)Mary A. Millner (1)Trudy R. Papson (1)
FEI number 3004753838 · most recent document Mar 4, 2025
About Dexcom, Inc.
How many FDA Form 483s has Dexcom, Inc. received?
FDA Intel has 1 Form 483 on file for Dexcom, Inc.; the most recent is dated Nov 7, 2024.
When was Dexcom, Inc. last inspected by FDA?
The most recent FDA inspection document on file for Dexcom, Inc. is a Form 483 dated Nov 7, 2024, for the site in San Diego, California.
What did FDA cite at Dexcom, Inc.?
The regulations cited most in the observations on file for Dexcom, Inc. are 21 CFR 820.30(c) (Design controls), 4 times; 21 CFR 820.75(a) (Process validation), 2 times; 21 CFR 820.100(a) (Corrective and preventive action), 1 time.
Has Dexcom, Inc. received an FDA warning letter?
Yes. FDA Intel has 3 FDA warning letters on file for Dexcom, Inc.; the most recent is dated Mar 4, 2025.