Company
United StatesSynthon Pharmaceuticals, Inc, Durham, NC – FDA Inspections
Inspection records and compliance data for Synthon Pharmaceuticals, Inc in Durham, North Carolina. 4 FDA inspections on record, last inspected May 18, 2012.
Company Profile
This profile covers Synthon Pharmaceuticals, Inc based in Durham, North Carolina, United States.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 0
- VAI
- 2
- NAI
- 2
- Form 483s
- 0
- Warning letters
- 0
First inspected April 3, 2009. Last inspected May 18, 2012.
Most cited issue areas
- Absence of Written Procedures1 inspection
- In process materials - conformance to written specs1 inspection
- Investigations of discrepancies, failures1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| May 18, 2012 | VAI | Human Drugs · Drug Quality Assurance | 782270 |
| March 30, 2010 | NAI | Human Drugs · Drug Quality Assurance | 659289 |
| March 30, 2010 | NAI | Human Drugs · Bioresearch Monitoring | 658237 |
| April 3, 2009 | VAI | Human Drugs · Drug Quality Assurance | 603514 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Synthon Pharmaceuticals, Inc
FEI Number
3001238189
Address
9000 Development Dr, Durham, North Carolina 27709, United States
Country
United States
ID: cf016655-8e6a-4594-a42e-98107c959c23