FDA issued a Warning Letter to Cardiac Designs Inc. on 8/7/2015 as a result of this inspection.
FDA investigators audited the Cardiac Designs - Round Rock, TX, United States facility and issued 11 inspectional observations (via FDA 483) on 02 Jul 2015.
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- Category: Medical Devices & Rad Health
- Number of Observations: 11
- Inspection end: 02 Jul 2015
- Location: Round Rock, United States
- FEI: 3010665082