Company
United StatesTetra Medical Supply Corp., Niles, IL – FDA Inspections
Inspection records and compliance data for Tetra Medical Supply Corp. in Niles, Illinois. 2 FDA inspections on record (1 OAI), 1 Form 483, last inspected September 28, 2017.
Company Profile
This profile covers Tetra Medical Supply Corp. based in Niles, Illinois, United States.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 1
- VAI
- 1
- NAI
- 0
- Form 483s
- 1
- Warning letters
- 0
First inspected April 22, 2016. Last inspected September 28, 2017.
Most cited issue areas
- Lack of or inadequate process validation2 inspections
- DHR - not or inadequately maintained1 inspection
- Documented evaluation1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| September 28, 2017 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1027329 |
| April 22, 2016 | OAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 975437 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Tetra Medical Supply Corp.
FEI Number
1418270
Address
6364 W Gross Point Rd, Niles, Illinois 60714, United States
Country
United States
ID: 435cc158-7a0f-4395-abd1-ab5c2e32eadb