FDA Inspection
Implants International Ltd.Implants International Ltd. – FDA Inspection, Jul 25, 2024
Record Details
This FDA Inspection record concerns Implants International Ltd., with an inspection on July 25, 2024, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
- Company
- Implants International Ltd.
- Inspection Date
- July 25, 2024
- Product Type
- Medical Devices & Rad Health
- Person
- Melissa A. Zuppe
View Company Profile
ID · ea476a43-f733-4f28-b2dd-dca271498a9d
Inspection Facts
- Inspection number
- 1249531
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 803.17(a)(3)Lack of System for Timely Submission of Reports
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.180Availability
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Implants International Ltd.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| December 21, 2023 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| September 24, 2009 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Implants International Ltd.
- FDA Inspection 1226451 - 2023-12-21
- FDA Inspection 613015 - 2009-09-24
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.