FDA Inspection
CDR Manufacturing Inc.CDR Manufacturing Inc. – FDA Inspection, Jan 7, 2014
Record Details
This FDA Inspection record concerns CDR Manufacturing Inc., with an inspection on January 7, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- CDR Manufacturing Inc.
- Inspection Date
- January 7, 2014
- Product Type
- Devices
View Company Profile
ID · a6b18e81-f1fd-4841-8bcb-0ec5c81fb886
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 860311
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
4- 21 CFR 820.198(a)Complaints
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.40(a)Document review, approval documentation
- 21 CFR 803.17Lack of Written MDR Procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of CDR Manufacturing Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| February 2, 2023 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 26, 2019 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for CDR Manufacturing Inc.
- FDA Inspection 1197245 - 2023-02-02
- FDA Inspection 1087615 - 2019-03-26
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