FDA Inspection
Carilion Materials ManagementCarilion Materials Management – FDA Inspection, Mar 2, 2011
Record Details
This FDA Inspection record concerns Carilion Materials Management, with an inspection on March 2, 2011, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- March 2, 2011
- Product Type
- Drugs
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ID · 300c68ee-a0df-4af1-8cf0-838f9ca8a3a1
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 712034
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
22- 21 CFR 211.188(b)(10)Records of any sampling performed
- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.188(b)(6)Inspection of packaging and labeling area
- 21 CFR 211.192Quality control unit review of records
- 21 CFR 211.137(a)Expiration date lacking
- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 111.12(c)Personnel - education, training, experience
- 21 CFR 211.198(a)Complaint Handling Procedure
- 21 CFR 211.170(b)Reserve samples identified, representative, stored
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Other FDA inspections of Carilion Materials Management
2| Date | Classification | Office | Project area |
|---|---|---|---|
| February 14, 2018 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| December 16, 2015 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Carilion Materials Management
- FDA Inspection 1041728 - 2018-02-14
- FDA Inspection 957601 - 2015-12-16
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