FDA issued a Warning Letter to Abbott (St Jude Medical Inc.) on 4/12/2017 as a result of this inspection.
FDA investigators audited the Abbott - Sylmar, CA, United States facility and issued inspectional observations (via FDA 483) on 17 Feb 2017.
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- Category: Medical Devices & Rad Health
- Inspection end: 17 Feb 2017
- Location: Sylmar, United States
- FEI: 2017865