FDA Inspection
QS CONTROL CORP.QS CONTROL CORP. – FDA Inspection, Jan 28, 2016
Record Details
This FDA Inspection record concerns QS CONTROL CORP., with an inspection on January 28, 2016, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- QS CONTROL CORP.
- Inspection Date
- January 28, 2016
- Product Type
- Devices
View Company Profile
ID · d8e478e7-3110-48ea-88bf-1a18a6f1eb9e
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 957986
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
8- 21 CFR 807.20(a)Devices not listed
- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 820.70(c)Environmental control Lack of or inadequate procedures
- 21 CFR 820.70(e)Contamination control, Lack of or inadequate procedures
- 21 CFR 803.17Lack of Written MDR Procedures
- 21 CFR 807.22(b)(1)Annual registration
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