SMC
FDA inspection history on file, 2025
- 1
- Form 483
Every document, by year
- Form 483
2025: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2025One Form 483.
Cited most
Across all SMC observations on file
- 21 CFR 803.17What 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
- 21 CFR 820.50(b)Purchasing controls1
The complete SMC file.
All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.
Documents
1 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2025-12-11 | 483 Form 483 | — | 3 | $99 |
Investigators on these documents
FEI number 3011221234 · most recent document Dec 11, 2025
About SMC
How many FDA Form 483s has SMC received?
FDA Intel has 1 Form 483 on file for SMC; the most recent is dated Dec 11, 2025.
When was SMC last inspected by FDA?
The most recent FDA inspection document on file for SMC is a Form 483 dated Dec 11, 2025.
What did FDA cite at SMC?
The regulations cited most in the observations on file for SMC are 21 CFR 803.17 (What are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me?), 1 time; 21 CFR 820.100(a) (Corrective and preventive action), 1 time; 21 CFR 820.50(b) (Purchasing controls), 1 time.