Company
United StatesEntrotech Life Sciences, Inc., Columbus, OH – FDA Inspections
Inspection records and compliance data for Entrotech Life Sciences, Inc. in Columbus, Ohio. 4 FDA inspections on record, 1 Form 483, last inspected July 01, 2024.
Company Profile
This profile covers Entrotech Life Sciences, Inc. based in Columbus, Ohio, United States.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 0
- VAI
- 1
- NAI
- 3
- Form 483s
- 1
- Warning letters
- 0
First inspected October 11, 2011. Last inspected July 1, 2024.
Most cited issue areas
- Design changes - Lack of or Inadequate Procedures1 inspection
- Design verification - Lack of or inadequate procedures1 inspection
- Lack of or inadequate procedures1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| July 1, 2024 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1242772 |
| August 15, 2018 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1062290 |
| October 4, 2017 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1028826 |
| October 11, 2011 | NAI | Medical Devices & Rad Health · Compliance: Devices | 749797 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Entrotech Life Sciences, Inc.
FEI Number
3011393407
Address
1245 Kinnear Rd, Columbus, Ohio 43212, United States
Country
United States
ID: ad58859b-753f-49f8-9fc8-37ed6f74a226