FDA Inspection
MOLD-TECH (TIANJIN) PLASTICS ELECTRIC CO., LTDMOLD-TECH (TIANJIN) PLASTICS ELECTRIC CO., LTD – FDA Inspection, Nov 18, 2014
Record Details
This FDA Inspection record concerns MOLD-TECH (TIANJIN) PLASTICS ELECTRIC CO., LTD, with an inspection on November 18, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- November 18, 2014
- Product Type
- Devices
View Company Profile
ID · 5e6009fe-d565-48ae-9f8f-74d8aca69fbf
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 904325
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
5- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 803.17Lack of Written MDR Procedures
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