FDA Inspection
Great Lakes Orthopedics, LLCGreat Lakes Orthopedics, LLC – FDA Inspection, Oct 23, 2015
Record Details
This FDA Inspection record concerns Great Lakes Orthopedics, LLC, with an inspection on October 23, 2015, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Great Lakes Orthopedics, LLC
- Inspection Date
- October 23, 2015
- Product Type
- Biologics
View Company Profile
ID · 048a1e6a-2215-464f-b144-93640eb74a0a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 949097
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
3- 21 CFR 1271.195(d)Documentation not maintained
- 21 CFR 1271.180(a)Procedures to meet core CTGP
- 21 CFR 1271.180(b)Review and approval-responsible person
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Great Lakes Orthopedics, LLC
4| Date | Classification | Office | Project area |
|---|---|---|---|
| July 9, 2018 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| November 26, 2013 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| October 17, 2011 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| January 5, 2010 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for Great Lakes Orthopedics, LLC
- FDA Inspection 1061276 - 2018-07-09
- FDA Inspection 857253 - 2013-11-26
- FDA Inspection 752336 - 2011-10-17
- FDA Inspection 638727 - 2010-01-05
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