FDA Inspection
Alpha Orthopedic Systems, LLCAlpha Orthopedic Systems, LLC – FDA Inspection, Apr 29, 2024
Record Details
This FDA Inspection record concerns Alpha Orthopedic Systems, LLC, with an inspection on April 29, 2024, issued by the Center for Biologics Evaluation and Research, covering biologics.
View Company Profile
ID · 55d7e089-3faa-4583-ac12-3892fa7371dd
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1237440
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
2- 21 CFR 1271.200(e)Documentation of maintenance and cleaning
- 21 CFR 1271.260(e)Storage temperatures recorded, maintained
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Alpha Orthopedic Systems, LLC
3| Date | Classification | Office | Project area |
|---|---|---|---|
| April 16, 2019 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| February 13, 2017 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| May 21, 2015 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for Alpha Orthopedic Systems, LLC
- FDA Inspection 1088137 - 2019-04-16
- FDA Inspection 999900 - 2017-02-13
- FDA Inspection 929378 - 2015-05-21
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.