FDA Inspection
AlsealAlseal – FDA Inspection, Jun 9, 2016
Record Details
This FDA Inspection record concerns Alseal, with an inspection on June 9, 2016, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Alseal
- Inspection Date
- June 9, 2016
- Product Type
- Devices
View Company Profile
ID · 79515380-fc87-4638-b98d-5be8f6ea3b98
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 976708
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
8- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(c)Design input - Lack of or inadequate procedures
- 21 CFR 820.250(a)Statistical techniques - Lack of or inadequate procedures
- 21 CFR 820.90(b)(1)Procedures for product review,disposition lack of/inadequate
- 21 CFR 820.198(e)Records of complaint investigation
- 21 CFR 820.30(f)Design verification - documentation
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.