FDA issued a Warning Letter to American Diagnostica, Inc. on 10/15/2004 as a result of this inspection.
FDA investigators audited the Sekisui Diagnostics - Stamford, CT, United States facility and issued inspectional observations (via FDA 483) on 10 Aug 2004.
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- Category: Medical Devices & Rad Health
- Inspection end: 10 Aug 2004
- Location: Stamford, United States
- FEI: 1220602