FDA Inspection
Medecor Pharma, LLCMedecor Pharma, LLC – FDA Inspection, Dec 4, 2014
Record Details
This FDA Inspection record concerns Medecor Pharma, LLC, with an inspection on December 4, 2014, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Medecor Pharma, LLC
- Inspection Date
- December 4, 2014
- Product Type
- Drugs
View Company Profile
ID · 31865e67-54e1-4f40-a0a1-a5692fc7403d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 905849
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
9- 21 CFR 211.150(b)Recall facilitation
- 21 CFR 211.160(b)(3)Acceptance of drug products
- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.198(a)Complaint Handling Procedure
- 21 CFR 211.130Procedures are written, and followed
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.22(a)Lack of quality control unit
- 21 CFR 211.166(a)Lack of written stability program
- 21 CFR 211.180(e)(2)Items to cover on annual reviews
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Medecor Pharma, LLC
4| Date | Classification | Office | Project area |
|---|---|---|---|
| May 27, 2026 | Not classified | New Orleans District Office | |
| November 30, 2018 | NAI | Center for Food Safety and Applied Nutrition | Foodborne Biological Hazards |
| November 28, 2017 | NAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| May 26, 2010 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Medecor Pharma, LLC
- FDA Inspection 1319526 - 2026-05-27
- FDA Inspection 1079061 - 2018-11-30
- FDA Inspection 1034804 - 2017-11-28
- FDA Inspection 664406 - 2010-05-26
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