Company
United StatesGentell, Inc, Bristol, PA – FDA Inspections
Inspection records and compliance data for Gentell, Inc in Bristol, Pennsylvania. 4 FDA inspections on record (1 OAI), 1 Form 483, last inspected September 16, 2026.
Company Profile
This profile covers Gentell, Inc based in Bristol, Pennsylvania, United States.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 1
- VAI
- 2
- NAI
- 0
- Unclassified
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected August 25, 2015. Last inspected September 16, 2026.
Most cited issue areas
- Lack of or inadequate procedures for labeling2 inspections
- Calibration, Inspection, etc. Procedures Lack of or Inadequ1 inspection
- Component identity verification1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| September 16, 2026 | Not classified | Medical Devices & Rad Health | 1342948 |
| December 12, 2019 | VAI | Human Drugs, Medical Devices & Rad Health · Drug Quality Assurance | 1112825 |
| December 13, 2016 | VAI | Foods & Cosmetics, Human Drugs, Medical Devices & Rad Health · Drug Quality Assurance | 997723 |
| August 25, 2015 | OAI | Medical Devices & Rad Health · Compliance: Devices | 938404 |
FDA documents
People (1)
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Company Information
Name
Gentell, Inc
FEI Number
1000522686
Address
180 Rittenhouse Cir, Bristol, Pennsylvania 19007, United States
Country
United States
ID: 96d27734-9ad8-46a1-9b0d-77fdcaaffb88