FDA Inspection
Renner & CoRenner & Co – FDA Inspection, Dec 21, 2015
Record Details
This FDA Inspection record concerns Renner & Co, with an inspection on December 21, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Renner & Co
- Inspection Date
- December 21, 2015
- Product Type
- Devices
View Company Profile
ID · 305a07ca-7b50-412e-8ecb-2e5842c64371
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 953257
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
7- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.60Identification procedures, Lack of or inadequate procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.20(e)Quality System Procedures
- 21 CFR 803.17Lack of Written MDR Procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Renner & Co
1| Date | Classification | Office | Project area |
|---|---|---|---|
| September 28, 2017 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Renner & Co
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.