FDA Inspection
Puracon GmbHPuracon GmbH – FDA Inspection, Aug 23, 2018
Record Details
This FDA Inspection record concerns Puracon GmbH, with an inspection on August 23, 2018, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
View Company Profile
ID · ee03fb3b-08e5-4ab8-a62b-2828e38c01c1
Inspection Facts
- Inspection number
- 1064787
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 803.17(a)(3)Lack of System for Timely Submission of Reports
- 21 CFR 820.90(b)(1)Procedures for product review,disposition lack of/inadequate
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Puracon GmbH
2| Date | Classification | Office | Project area |
|---|---|---|---|
| February 26, 2026 | Not classified | Office of Inspections and Investigations | |
| August 7, 2014 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Puracon GmbH
- FDA Inspection 1312646 - 2026-02-26
- FDA Inspection 896254 - 2014-08-07
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.