FDA issued a Warning Letter to Datascope Corporation on 9/11/2018 as a result of this inspection.
FDA investigators audited the Datascope - Fairfield, NJ, United States facility and issued inspectional observations (via FDA 483) on 11 Jun 2018.
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- Category: Medical Devices & Rad Health
- Inspection end: 11 Jun 2018
- Location: Fairfield, United States
- FEI: 1000222374