Company
United StatesGateway Analytical, LLC., Gibsonia, PA – FDA Inspections
Inspection records and compliance data for Gateway Analytical, LLC. in Gibsonia, PA. 4 FDA inspections on record, 1 Form 483, last inspected March 20, 2026.
Company Profile
This profile covers Gateway Analytical, LLC. based in Gibsonia, PA, United States.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 0
- VAI
- 0
- NAI
- 3
- Unclassified
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected November 5, 2012. Last inspected March 20, 2026.
Most cited issue areas
- Written procedures not established/followed1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| March 20, 2026 | Not classified | Human Drugs · Drug Quality Assurance | 1308690 |
| September 16, 2022 | NAI | Human Drugs · Drug Quality Assurance | 1180958 |
| January 15, 2015 | NAI | Human Drugs · Drug Quality Assurance | 910319 |
| November 5, 2012 | NAI | Human Drugs · Drug Quality Assurance | 806291 |
FDA documents
People (5)
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Company Information
Name
Gateway Analytical, LLC.
FEI Number
3009255642
Address
5316 William Flynn Hwy., Gibsonia, PA 15044, United States
Country
United States
ID: 9ef2f86f-03e6-464f-85c4-35a2ef6d82b9