FDA Inspection
Cathay Manufacturing Corp.Cathay Manufacturing Corp. – FDA Inspection, Nov 27, 2014
Record Details
This FDA Inspection record concerns Cathay Manufacturing Corp., with an inspection on November 27, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Cathay Manufacturing Corp.
- Inspection Date
- November 27, 2014
- Product Type
- Devices
View Company Profile
ID · ab6dbbad-9566-4a30-9d16-32b29f4b955a
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 906061
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
5- 21 CFR 820.184DHR - not or inadequately maintained
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.198(e)Records of complaint investigation
- 21 CFR 803.17Lack of Written MDR Procedures
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