Overview
- 3 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-02-26.
At a glance
Inspections
3
Form 483s
2
EIRs
1
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 23 Feb 2026 – 26 Feb 2026 | Medical Devices & Rad Health | Clean | |
| 20 Aug 2018 – 23 Aug 2018 | Medical Devices & Rad Health | 483 | View 483 → |
| 4 Aug 2014 – 7 Aug 2014 | Medical Devices & Rad Health | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
23 Aug 2018
21 CFR 803.17(a)(3)
Lack of System for Timely Submission of Reports
Cited by Catherine J Laufmann
23 Aug 2018
21 CFR 803.17(a)(3)
Lack of System for Timely Submission of Reports
Cited by Catherine J Laufmann
23 Aug 2018
21 CFR 820.90(b)(1)
Procedures for product review,disposition lack of/inadequate
Cited by Catherine J Laufmann
23 Aug 2018
21 CFR 820.90(b)(1)
Procedures for product review,disposition lack of/inadequate
Cited by Catherine J Laufmann
7 Aug 2014
21 CFR 820.22
Quality audits - Lack of or inadequate procedures
Cited by Catherine J Laufmann
Investigators
FDA investigators tied to this site in the record.
Catherine J Laufmann2 insp.
Benjamin E Bowen1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.90(b)(1) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 803.17(a)(3) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.198(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.22 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.75(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Puracon GmbH's 2 Form 483s
Verbatim observations and recurring CFR citations, so your team knows what this site gets cited for.
- The site's full inspection history, with every Form 483 and its outcome
- Warning letters and recalls tied to the company behind it
- Whether recurring CFR citations get closed out or repeat