FDA Inspection
Great Lakes Orthopedics, LLCGreat Lakes Orthopedics, LLC – FDA Inspection, Jan 5, 2010
Record Details
This FDA Inspection record concerns Great Lakes Orthopedics, LLC, with an inspection on January 5, 2010, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Great Lakes Orthopedics, LLC
- Inspection Date
- January 5, 2010
- Product Type
- Biologics
View Company Profile
ID · 4e8a790c-e4cf-4744-9406-910b1eab29f2
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 638727
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
4- 21 CFR 1271.200(e)Documentation of maintenance and cleaning
- 21 CFR 1271.200(d)Inspected routinely
- 21 CFR 1271.160(c)Quality audits performed periodically
- 21 CFR 1271.160(b)(6)Deviations--Investigation, documenting, trending
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 |
| October 23, 2015 | VAI | 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 |
Other documents for Great Lakes Orthopedics, LLC
- FDA Inspection 1061276 - 2018-07-09
- FDA Inspection 949097 - 2015-10-23
- FDA Inspection 857253 - 2013-11-26
- FDA Inspection 752336 - 2011-10-17
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