Company
GermanyPuracon GmbH, Rosenheim, Germany – FDA Inspections
Inspection records and compliance data for Puracon GmbH in Rosenheim. 3 FDA inspections on record, 1 Form 483, last inspected February 26, 2026.
Company Profile
This profile covers Puracon GmbH based in Rosenheim, Germany.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 0
- NAI
- 1
- Unclassified
- 2
- Form 483s
- 1
- Warning letters
- 0
First inspected August 7, 2014. Last inspected February 26, 2026.
Most cited issue areas
- Lack of System for Timely Submission of Reports1 inspection
- Procedures for product review,disposition lack of/inadequate1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| February 26, 2026 | Not classified | Medical Devices & Rad Health | 1312646 |
| August 23, 2018 | Not classified | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1064787 |
| August 7, 2014 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 896254 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Puracon GmbH
FEI Number
3004638532
Address
Isarstr. 1, Rosenheim, Germany
Country
Germany
ID: 7833e10a-980e-4ccd-8b75-c9ce6523d62c