FDA Inspection
Datascope Corp.Datascope Corp. – FDA Inspection, Oct 17, 2013
Record Details
This FDA Inspection record concerns Datascope Corp., with an inspection on October 17, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Datascope Corp.
- Inspection Date
- October 17, 2013
- Product Type
- Devices
View Company Profile
ID · 19a036ea-454a-4a19-8fc5-40fead1912c7
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 853578
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 820.20(c)Management review - defined interval, sufficient frequency
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.120Lack of or inadequate procedures for labeling
- 21 CFR 820.90(a)Nonconforming product control
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