FDA Inspection
Gueldenkron Fruchtsaft GmbHGueldenkron Fruchtsaft GmbH – FDA Inspection, May 28, 2025
Record Details
This FDA Inspection record concerns Gueldenkron Fruchtsaft GmbH, with an inspection on May 28, 2025, issued by the Office of Inspections and Investigations, covering foods & cosmetics.
View Company Profile
ID · 5ad56d4a-31a0-4979-b97b-d6393695b0f9
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1271323
- FDA center
- Foods & Cosmetics
- Project area
- Foodborne Biological Hazards
- Outcome
- Form 483 issued
FDA Citations
8- 21 CFR 108.35(c)(3)(i)Process adherence
- 21 CFR 108.35(c)(3)(ii)Process information availability
- 21 CFR 113.10Operators
- 21 CFR 113.40(g)(1)(i)(A)No accurate TID
- 21 CFR 113.40(g)(1)(i)(B)(1)Recorder range, chart graduations
- 21 CFR 113.40(g)(1)(i)(G)Holding tube - heated, slope
- 21 CFR 113.40(g)(1)(ii)(A)Startup - commercial sterility
- 21 CFR 113.83Scheduled processes not established
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.