FDA Inspection
May Medical, LLCMay Medical, LLC – FDA Inspection, Dec 3, 2009
Record Details
This FDA Inspection record concerns May Medical, LLC, with an inspection on December 3, 2009, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- May Medical, LLC
- Inspection Date
- December 3, 2009
- Product Type
- Biologics
View Company Profile
ID · 2949483f-235a-47aa-9c8b-5d8a2193fea6
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 630184
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
7- 21 CFR 1271.200(a)Capable of valid results
- 21 CFR 1271.265(a)Acceptance criteria designed to prevent CD
- 21 CFR 1271.160(c)Quality audits performed periodically
- 21 CFR 1271.200(b)Procedures inadequate
- 21 CFR 1271.320(a)Procedures re complaints
- 21 CFR 1271.160(b)(2)Sharing of information (general)
- 21 CFR 1271.160(b)(2)(iii)Risk assessment, quarantine, recall, FDA
Full citation text and observation details available on the Dashboard.
Other FDA inspections of May Medical, LLC
3| Date | Classification | Office | Project area |
|---|---|---|---|
| November 24, 2015 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| December 20, 2013 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| December 9, 2011 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for May Medical, LLC
- FDA Inspection 951942 - 2015-11-24
- FDA Inspection 859894 - 2013-12-20
- FDA Inspection 756910 - 2011-12-09
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