FDA Inspection
DeRoyal Cientifica De Latinoamerica S.R.L.DeRoyal Cientifica De Latinoamerica S.R.L. – FDA Inspection, Feb 28, 2013
Record Details
This FDA Inspection record concerns DeRoyal Cientifica De Latinoamerica S.R.L., with an inspection on February 28, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- February 28, 2013
- Product Type
- Devices
View Company Profile
ID · 80b4a9b4-b412-41c3-839f-6001633eec00
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 821533
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
8- 21 CFR 820.184DHR - not or inadequately maintained
- 21 CFR 820.198(a)Complaints
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.40Procedures not adequately established or maintained
- 21 CFR 803.18(e)Info not obtained or submitted
- 21 CFR 820.70(c)Environmental control Lack of or inadequate procedures
- 21 CFR 820.22Quality Audit/Reaudit - documentation
- 21 CFR 820.20(a)Quality policy and objectives
Full citation text and observation details available on the Dashboard.
Other FDA inspections of DeRoyal Cientifica De Latinoamerica S.R.L.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| May 11, 2017 | Not classified | Office of Inspections and Investigations | Postmarket Assurance: Devices |
| October 2, 2014 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for DeRoyal Cientifica De Latinoamerica S.R.L.
- FDA Inspection 1018303 - 2017-05-11
- FDA Inspection 900907 - 2014-10-02
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.