Abbott Diabetes Care, Inc
FDA inspection history in Alameda, California, 2010 to 2026
- 2
- Warning letters
- 1
- Form 483
Every document, by year
- Warning letter
- Form 483
2010: one warning letter; 2015: one Form 483; 2026: one warning letter.
The story so far
Built from the dates and citations on the documents themselves.
- 2010One warning letter, at Alameda, California.
- 2015One Form 483, at Alameda, California.
- 2026One warning letter, at Alameda, California.
Cited most
Across all Abbott Diabetes Care observations on file
- 21 CFR 803.50(a)(2)If I am a manufacturer, what reporting requirements apply to me?1
- 21 CFR 820.198(a)Complaint files1
- 21 CFR 820.25(a)Personnel1
The complete Abbott Diabetes Care file.
All 3 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Alameda, California
Two warning letters and one Form 483 · 2010 to 2026 · 3 observations
Latest: Warning letter, Jan 23, 2026 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2026-01-23 | Warning letter Warning letter | Alameda, California | — | $99 |
| 2015-10-22 | 483 Form 483 | Alameda, California | 3 | $99 |
| 2010-07-02 | Warning letter Warning letter | Alameda, California | — | $99 |
Investigators on these documents
FEI number 3002803444 · most recent document Jan 23, 2026
About Abbott Diabetes Care, Inc
How many FDA Form 483s has Abbott Diabetes Care, Inc received?
FDA Intel has 1 Form 483 on file for Abbott Diabetes Care, Inc; the most recent is dated Oct 22, 2015.
When was Abbott Diabetes Care, Inc last inspected by FDA?
The most recent FDA inspection document on file for Abbott Diabetes Care, Inc is a Form 483 dated Oct 22, 2015, for the site in Alameda, California.
What did FDA cite at Abbott Diabetes Care, Inc?
The regulations cited most in the observations on file for Abbott Diabetes Care, Inc are 21 CFR 803.50(a)(2) (If I am a manufacturer, what reporting requirements apply to me?), 1 time; 21 CFR 820.198(a) (Complaint files), 1 time; 21 CFR 820.25(a) (Personnel), 1 time.
Has Abbott Diabetes Care, Inc received an FDA warning letter?
Yes. FDA Intel has 2 FDA warning letters on file for Abbott Diabetes Care, Inc; the most recent is dated Jan 23, 2026.