FDA issued a Warning Letter to Datascope Corp. on 2/6/2019 as a result of this inspection.
FDA investigators audited the Datascope - Mahwah, NJ, United States facility and issued inspectional observations (via FDA 483) on 03 Oct 2018.
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- Category: Medical Devices & Rad Health
- Inspection end: 03 Oct 2018
- Location: Mahwah, United States
- FEI: 3001418283