FDA Inspection
Longhorn Vaccines And Diagnostics LLCLonghorn Vaccines And Diagnostics LLC – FDA Inspection, Aug 14, 2026
Record Details
This FDA Inspection record concerns Longhorn Vaccines And Diagnostics LLC, with an inspection on August 14, 2026, issued by the Baltimore District Office, covering medical devices & rad health.
- Inspection Date
- August 14, 2026
- Product Type
- Medical Devices & Rad Health
View Company Profile
ID · 9dbff495-1894-45a8-ba04-5be394002a7e
Inspection Facts
- Inspection number
- 1331002
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
5- ISO 13485:2016 Clause 4.1.6QMS software not validated prior to use or changes
- ISO 13485:2016 Clause 7.3.9Requirements for design and development changes not met before implementation
- ISO 13485:2016 Clause 7.4.1Supplier monitoring and re-evaluation not planned
- ISO 13485:2016 Clause 7.4.3Purchased product verification activities not established or implemented
- ISO 13485:2016 Clause 7.5.11Procedures for preserving the conformity of product not documented
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Longhorn Vaccines And Diagnostics LLC
1| Date | Classification | Office | Project area |
|---|---|---|---|
| October 30, 2025 | OAI | Baltimore District Office | Compliance: Medical Devices |
Other documents for Longhorn Vaccines And Diagnostics LLC
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.