FDA issued a Warning Letter to St. Jude Medical (CardioMEMS) on 9/30/2015 as a result of this inspection.
FDA investigators audited the Abbott Labs - Atlanta, GA, United States facility and issued 12 inspectional observations (via FDA 483) on 26 Jun 2015.
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- Category: Medical Devices & Rad Health
- Number of Observations: 12
- Inspection end: 26 Jun 2015
- Location: Atlanta, United States
- FEI: 3004936110