FDA Inspection
Ceragroup Industries IncCeragroup Industries Inc – FDA Inspection, Jan 10, 2012
Record Details
This FDA Inspection record concerns Ceragroup Industries Inc, with an inspection on January 10, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Ceragroup Industries Inc
- Inspection Date
- January 10, 2012
- Product Type
- Devices
View Company Profile
ID · ee51f970-7cc9-4621-984b-232021c77eaf
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 762996
- 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 820.30(a)Design control - no procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 803.17Lack of Written MDR Procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Ceragroup Industries Inc
4| Date | Classification | Office | Project area |
|---|---|---|---|
| April 15, 2025 | NAI | Florida District Office | Postmarket Assurance: Medical Devices |
| October 11, 2022 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| November 25, 2019 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| August 18, 2015 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Ceragroup Industries Inc
- FDA Inspection 1267038 - 2025-04-15
- FDA Inspection 1181342 - 2022-10-11
- FDA Inspection 1111123 - 2019-11-25
- FDA Inspection 938610 - 2015-08-18
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.