Company
United StatesGyrus Acmi, In., Westborough, MA – FDA Inspections
Inspection records and compliance data for Gyrus Acmi, In. in Westborough, Massachusetts. 4 FDA inspections on record, 1 Form 483, last inspected October 17, 2025.
Company Profile
This profile covers Gyrus Acmi, In. based in Westborough, Massachusetts, United States.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 0
- VAI
- 1
- NAI
- 1
- Unclassified
- 2
- Form 483s
- 1
- Warning letters
- 0
First inspected June 24, 2010. Last inspected October 17, 2025.
Most cited issue areas
- Individual Report of Malfunction1 inspection
- Lack of Written MDR Procedures1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| October 17, 2025 | Not classified | Medical Devices & Rad Health | 1294514 |
| June 21, 2018 | Not classified | Medical Devices & Rad Health | 1094512 |
| June 11, 2013 | VAI | Medical Devices & Rad Health · Compliance: Devices | 837099 |
| June 24, 2010 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 668592 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Gyrus Acmi, In.
FEI Number
3003790304
Address
800 W Park Dr, Westborough, Massachusetts 01581, United States
Country
United States
ID: 8b143956-34ad-4a45-8d6c-4e93b2479e31