Company
United StatesGyrus ACMI, Inc., Littleton, MA – FDA Inspections
Inspection records and compliance data for Gyrus ACMI, Inc. in Littleton, Massachusetts. 2 FDA inspections on record, 1 Form 483, 1 warning letter, last inspected November 02, 2023.
Company Profile
This profile covers Gyrus ACMI, Inc. based in Littleton, Massachusetts, United States.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 1
- NAI
- 1
- Form 483s
- 1
- Warning letters
- 1
First inspected August 17, 2016. Last inspected November 2, 2023.
Most cited issue areas
- DHR - not or inadequately maintained1 inspection
- Lack of or inadequate complaint procedures1 inspection
- Lack of or inadequate procedures1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| November 2, 2023 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1221779 |
| August 17, 2016 | NAI | Medical Devices & Rad Health · Compliance: Devices | 980899 |
FDA documents
Form 483s (1)
Warning Letters (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Gyrus ACMI, Inc.
FEI Number
3003696010
Address
1 Monarch Dr , Ste 102, Littleton, Massachusetts 01460, United States
Country
United States
ID: 83de7ea8-de1b-4b07-805a-975da3d94ea6