FDA Inspection
Old School Medical LLCOld School Medical LLC – FDA Inspection, Apr 6, 2011
Record Details
This FDA Inspection record concerns Old School Medical LLC, with an inspection on April 6, 2011, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Old School Medical LLC
- Inspection Date
- April 6, 2011
- Product Type
- Biologics
View Company Profile
ID · 4cc6adcc-006f-4193-b187-1eaf1a7817e4
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 721393
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
4- 21 CFR 1271.270(b)Management system re: core CGTPs
- 21 CFR 1271.180(a)Procedures to meet core CTGP
- 21 CFR 1271.260(a)Contamination, mix ups, improper release
- 21 CFR 1271.260(e)Storage temperatures recorded, maintained
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Old School Medical LLC
4| Date | Classification | Office | Project area |
|---|---|---|---|
| June 12, 2018 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| March 16, 2016 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| December 18, 2012 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| December 18, 2012 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for Old School Medical LLC
- FDA Inspection 1057444 - 2018-06-12
- FDA Inspection 968505 - 2016-03-16
- FDA Inspection 810740 - 2012-12-18
- FDA Inspection 810739 - 2012-12-18
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