FDA Inspection
Hubei Weikang Protective Products Co., Ltd.Hubei Weikang Protective Products Co., Ltd. – FDA Inspection, Jun 4, 2015
Record Details
This FDA Inspection record concerns Hubei Weikang Protective Products Co., Ltd., with an inspection on June 4, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- June 4, 2015
- Product Type
- Devices
View Company Profile
ID · cde5841a-b2f6-447a-a3c4-0d5c4dacaf95
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 933112
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
7- 21 CFR 820.40Procedures not adequately established or maintained
- 21 CFR 820.70(b)Production and Process Change Procedures, lack of or Inad.
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.60Identification procedures, Lack of or inadequate procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
- 21 CFR 820.75(c)Documentation - review in response to changes or deviations
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Hubei Weikang Protective Products Co., Ltd.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| October 30, 2019 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Hubei Weikang Protective Products Co., Ltd.
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.