Smiths Medical ASD Inc
FDA inspection history across 2 sites, 2021 to 2025
- 2
- Warning letters
- 1
- Form 483
Every document, by year
- Warning letter
- Form 483
2021: one warning letter and one Form 483; 2025: one warning letter.
The story so far
Built from the dates and citations on the documents themselves.
- 2021One warning letter and one Form 483, at Minneapolis, Minnesota.
- 2025One warning letter, at San Clemente, California.
Cited most
Across all Smiths Medical ASD observations on file
- 21 CFR 820.30(c)Design controls4
- 21 CFR 820.198(a)Complaint files2
- 21 CFR 8201
- 21 CFR 803.17(a)(2)What are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me?1
- 21 CFR 820.100(a)Corrective and preventive action1
The complete Smiths Medical ASD 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
Minneapolis, Minnesota
One warning letter and one Form 483 · 2021 · 8 observations
Latest: Warning letter, Oct 1, 2021 →San Clemente, California
One warning letter · 2025
Latest: Warning letter, Apr 4, 2025 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2025-04-04 | Warning letter Warning letter | San Clemente, California | — | $99 |
| 2021-10-01 | Warning letter Warning letter | Minneapolis, Minnesota | — | $99 |
| 2021-04-30 | 483 Form 483 | Minneapolis, Minnesota | 8 | $99 |
Investigators on these documents
FEI number 3012307300 · most recent document Apr 4, 2025
About Smiths Medical ASD Inc
How many FDA Form 483s has Smiths Medical ASD Inc received?
FDA Intel has 1 Form 483 on file for Smiths Medical ASD Inc; the most recent is dated Apr 30, 2021.
When was Smiths Medical ASD Inc last inspected by FDA?
The most recent FDA inspection document on file for Smiths Medical ASD Inc is a Form 483 dated Apr 30, 2021, for the site in Minneapolis, Minnesota.
What did FDA cite at Smiths Medical ASD Inc?
The regulations cited most in the observations on file for Smiths Medical ASD Inc are 21 CFR 820.30(c) (Design controls), 4 times; 21 CFR 820.198(a) (Complaint files), 2 times; 21 CFR 820, 1 time.
Has Smiths Medical ASD Inc received an FDA warning letter?
Yes. FDA Intel has 2 FDA warning letters on file for Smiths Medical ASD Inc; the most recent is dated Apr 4, 2025.