FDA Inspection
Datascope Corp.Datascope Corp. – FDA Inspection, Oct 3, 2018
Record Details
This FDA Inspection record concerns Datascope Corp., with an inspection on October 3, 2018, issued by the Center for Devices and Radiological Health, covering devices.
- People
- Frank J. Marciniak (Issuing Officer)
- Melissa A. Zuppe
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ID · 332eaa4a-a665-4da7-bc0b-a560d4343bbd
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1071011
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
- Enforcement
- Warning Letter
FDA Citations
9- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.184DHR content
- 21 CFR 820.30(f)Design verification - output does not meet input requirement
- 21 CFR 820.30(g)Design validation- Lack of or inadequate procedures
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.40(a)Document review, approval by designated individual
- 21 CFR 820.50(a)(1)Evaluation and Selection, Suppliers, Contractors, etc.
- 21 CFR 820.90(b)(2)Product rework procedures, Lack of or inadequate procedures
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Other FDA inspections of Datascope Corp.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| April 13, 2010 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| April 1, 2010 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Datascope Corp.
- FDA Inspection 657359 - 2010-04-13
- FDA Inspection 656388 - 2010-04-01
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