Agile Devices, Inc
FDA inspection history in Newton Center, Massachusetts, 2026
- 1
- Form 483
Every document, by year
- Form 483
2026: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2026One Form 483, at Newton Center, Massachusetts.
Cited most
Across all Agile Devices observations on file
- ISO 13485:2016 Clause 8.2.12
- ISO 13485:2016 Clause 4.1.5What is the scope of this subpart?1
- ISO 13485:2016 Clause 7.3.9Definitions1
- ISO 13485:2016 Clause 8.5.21
The complete Agile Devices file.
All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.
Sites
Newton Center, Massachusetts
One Form 483 · 2026 · 5 observations
Latest: Form 483, Feb 20, 2026 →
Documents
1 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2026-02-20 | 483 Form 483 | Newton Center, Massachusetts | 5 | $99 |
Investigators on these documents
FEI number 3023167283 · most recent document Feb 20, 2026
About Agile Devices, Inc
How many FDA Form 483s has Agile Devices, Inc received?
FDA Intel has 1 Form 483 on file for Agile Devices, Inc; the most recent is dated Feb 20, 2026.
When was Agile Devices, Inc last inspected by FDA?
The most recent FDA inspection document on file for Agile Devices, Inc is a Form 483 dated Feb 20, 2026, for the site in Newton Center, Massachusetts.
What did FDA cite at Agile Devices, Inc?
The regulations cited most in the observations on file for Agile Devices, Inc are ISO 13485:2016 Clause 8.2.1, 2 times; ISO 13485:2016 Clause 4.1.5 (What is the scope of this subpart?), 1 time; ISO 13485:2016 Clause 7.3.9 (Definitions), 1 time.