FDA issued a Warning Letter to Synthes, Inc. on 11/5/2004 as a result of this inspection.
FDA investigators audited the Synthes USA - West Chester, PA, United States facility and issued inspectional observations (via FDA 483) on 18 Jun 2004.
Product details
- Category: Medical Devices & Rad Health
- Inspection end: 18 Jun 2004
- Location: West Chester, United States
- FEI: 2939274
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