FDA Inspection
ALN S.A.R.L.ALN S.A.R.L. – FDA Inspection, Sep 13, 2012
Record Details
This FDA Inspection record concerns ALN S.A.R.L., with an inspection on September 13, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- ALN S.A.R.L.
- Inspection Date
- September 13, 2012
- Product Type
- Devices
View Company Profile
ID · f1c125f4-28fe-4282-ae5b-334a1c0eb272
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 802355
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
5- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 820.250(b)Sampling plans
- 21 CFR 820.70(i)Software validation for automated processes
- 21 CFR 820.184DHR content
- 21 CFR 803.17Lack of Written MDR Procedures
Full citation text and observation details available on the Dashboard.
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.