FDA Inspection
Zhongshan Bisen Plastic Electronic Products Co., Ltd.Zhongshan Bisen Plastic Electronic Products Co., Ltd. – FDA Inspection, Aug 24, 2017
Record Details
This FDA Inspection record concerns Zhongshan Bisen Plastic Electronic Products Co., Ltd., with an inspection on August 24, 2017, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
- Inspection Date
- August 24, 2017
- Product Type
- Medical Devices & Rad Health
View Company Profile
ID · d64a4c43-6c1b-409d-865d-26d5c5f5fbbf
Inspection Facts
- Inspection number
- 1024083
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.100(b)Documentation
- 21 CFR 820.30(g)Design validation- Lack of or inadequate procedures
Full citation text and observation details available on the Dashboard.
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.