Company
United StatesGyrus ACMI, Inc., Bartlett, TN – FDA Inspections
Inspection records and compliance data for Gyrus ACMI, Inc. in Bartlett, Tennessee. 4 FDA inspections on record, last inspected May 02, 2022.
Company Profile
This profile covers Gyrus ACMI, Inc. based in Bartlett, Tennessee, United States.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 0
- VAI
- 1
- NAI
- 3
- Form 483s
- 0
- Warning letters
- 0
First inspected September 15, 2010. Last inspected May 2, 2022.
Most cited issue areas
- Design history file1 inspection
- Design validation - documentation1 inspection
- Documentation1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| May 2, 2022 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1170310 |
| July 1, 2016 | NAI | Medical Devices & Rad Health · Compliance: Devices | 977394 |
| September 18, 2013 | VAI | Medical Devices & Rad Health · Compliance: Devices | 848969 |
| September 15, 2010 | NAI | Medical Devices & Rad Health · Compliance: Devices | 683599 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Gyrus ACMI, Inc.
FEI Number
1037007
Address
2925 Appling Rd, Bartlett, Tennessee 38133, United States
Country
United States
ID: 1135a75b-f1b4-41d1-8fdd-44a5b2891a6f