FDA Inspection
Surgi-Pak Inc. DBA National Hospital PackagingSurgi-Pak Inc. DBA National Hospital Packaging – FDA Inspection, Oct 17, 2019
Record Details
This FDA Inspection record concerns Surgi-Pak Inc. DBA National Hospital Packaging, with an inspection on October 17, 2019, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- October 17, 2019
- Product Type
- Devices
View Company Profile
ID · 54a43576-d084-4117-a707-dfccab330994
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1106707
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
6- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.75(b)Lack/Inad procedure-Monitoring/Control of Validated Proces
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.22Quality Audit/Reaudit - documentation
- 21 CFR 820.50(a)(1)Documented evaluation
- 21 CFR 803.17Lack of Written MDR Procedures
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