FDA Inspection
Datascope Corp.FDA Inspection 1055241 - Datascope Corp. - June 11, 2018
Record Details
This FDA Inspection record concerns Datascope Corp., with an inspection on June 11, 2018, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Datascope Corp.
- Inspection Date
- June 11, 2018
- Product Type
- Devices
View Company Profile
ID · 0945a8f2-6dc9-48b9-88cf-c25fe8a3b614
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1055241
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
11- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 806.10(b)Time to report - 10 days
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.30(e)Design review - Lack of or inadequate procedures
- 21 CFR 820.75(b)Lack/Inad procedure-Monitoring/Control of Validated Proces
- 21 CFR 820.70(e)Contamination control, Lack of or inadequate procedures
- 21 CFR 820.198(e)Records of complaint investigation
- 21 CFR 820.50(a)Evaluation of suppliers, contractors, etc., requirements
Showing 10 of 11 citations.
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Other FDA inspections of Datascope Corp.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| February 2, 2023 | Not classified | New Jersey District Office | |
| March 24, 2010 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Datascope Corp.
- FDA Inspection 1197368 - 2023-02-02
- FDA Inspection 656265 - 2010-03-24
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