FDA Inspection
Synthon Pharmaceuticals, IncSynthon Pharmaceuticals, Inc – FDA Inspection, May 18, 2012
Record Details
This FDA Inspection record concerns Synthon Pharmaceuticals, Inc, with an inspection on May 18, 2012, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Synthon Pharmaceuticals, Inc
- Inspection Date
- May 18, 2012
- Product Type
- Drugs
View Company Profile
ID · e84d1666-82c0-4b8b-8e08-0c3bdf600134
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 782270
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
3- 21 CFR 211.160(b)(2)In process materials - conformance to written specs
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.192Investigations of discrepancies, failures
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Other FDA inspections of Synthon Pharmaceuticals, Inc
3| Date | Classification | Office | Project area |
|---|---|---|---|
| March 30, 2010 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 30, 2010 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| April 3, 2009 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Synthon Pharmaceuticals, Inc
- FDA Inspection 659289 - 2010-03-30
- FDA Inspection 658237 - 2010-03-30
- FDA Inspection 603514 - 2009-04-03
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