FDA Inspection
Midway Medical Products, Inc.Midway Medical Products, Inc. – FDA Inspection, Nov 22, 2013
Record Details
This FDA Inspection record concerns Midway Medical Products, Inc., with an inspection on November 22, 2013, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- November 22, 2013
- Product Type
- Biologics
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ID · 3e92d12b-14d0-412c-ac70-54caeb935e16
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 856462
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
10- 21 CFR 1271.265(d)Shipping conditions appropriate
- 21 CFR 1271.290(b)Establishing a system
- 21 CFR 1271.195(b)Periodic inspection
- 21 CFR 1271.170(c)Trained or re-trained as necessary
- 21 CFR 1271.265(f)Return to inventory--procedures
- 21 CFR 1271.320(a)Procedures re complaints
- 21 CFR 1271.180(a)Design adequate to bar spread of CD"s
- 21 CFR 1271.270(a)Accurate, indelible, legible
- 21 CFR 1271.260(a)Contamination, mix ups, improper release
- 21 CFR 1271.260(e)Storage temperatures recorded, maintained
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Other FDA inspections of Midway Medical Products, Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| June 16, 2011 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| June 22, 2009 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for Midway Medical Products, Inc.
- FDA Inspection 731378 - 2011-06-16
- FDA Inspection 590932 - 2009-06-22
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