FDA Inspection
Wright Medical Technology, Inc. - District Service Center - St. LouisWright Medical Technology, Inc. - District Service Center - St. Louis – FDA Inspection, Feb 4, 2015
Record Details
This FDA Inspection record concerns Wright Medical Technology, Inc. - District Service Center - St. Louis, with an inspection on February 4, 2015, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- February 4, 2015
- Product Type
- Biologics
View Company Profile
ID · 17ae6e85-3439-4f17-95d7-0c89b112dbb3
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 912469
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
5- 21 CFR 1271.290(d)Recording I.D. code and type of HCT/P
- 21 CFR 1271.160(b)(6)Deviations--evaluation, cause, corrective action
- 21 CFR 1271.180(c)Availability of procedures
- 21 CFR 1271.260(e)Storage temperatures recorded, maintained
- 21 CFR 1271.160(b)(4)Training of personnel
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Wright Medical Technology, Inc. - District Service Center - St. Louis
3| Date | Classification | Office | Project area |
|---|---|---|---|
| June 14, 2022 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| May 23, 2017 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| November 27, 2013 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for Wright Medical Technology, Inc. - District Service Center - St. Louis
- FDA Inspection 1173188 - 2022-06-14
- FDA Inspection 1015147 - 2017-05-23
- FDA Inspection 857062 - 2013-11-27
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.