Arch Medical Solutions - Elkhart
FDA inspection history in Elkhart, Indiana, 2024
- 1
- Form 483
Every document, by year
- Form 483
2024: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2024One Form 483, at Elkhart, Indiana.
Cited most
Across all Arch Medical Solutions - Elkhart observations on file
- 21 CFR 820.75(a)Process validation2
- 21 CFR 820.198(a)Complaint files1
- 21 CFR 820.90(a)Nonconforming product1
The complete Arch Medical Solutions - Elkhart file.
All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.
Sites
Elkhart, Indiana
One Form 483 · 2024 · 4 observations
Latest: Form 483, Dec 18, 2024 →
Documents
1 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2024-12-18 | 483 Form 483 | Elkhart, Indiana | 4 | $99 |
Investigators on these documents
FEI number 3009923627 · most recent document Dec 18, 2024
About Arch Medical Solutions - Elkhart
How many FDA Form 483s has Arch Medical Solutions - Elkhart received?
FDA Intel has 1 Form 483 on file for Arch Medical Solutions - Elkhart; the most recent is dated Dec 18, 2024.
When was Arch Medical Solutions - Elkhart last inspected by FDA?
The most recent FDA inspection document on file for Arch Medical Solutions - Elkhart is a Form 483 dated Dec 18, 2024, for the site in Elkhart, Indiana.
What did FDA cite at Arch Medical Solutions - Elkhart?
The regulations cited most in the observations on file for Arch Medical Solutions - Elkhart are 21 CFR 820.75(a) (Process validation), 2 times; 21 CFR 820.198(a) (Complaint files), 1 time; 21 CFR 820.90(a) (Nonconforming product), 1 time.