FDA Inspection
Medline Industries IncMedline Industries Inc – FDA Inspection, Sep 25, 2009
Record Details
This FDA Inspection record concerns Medline Industries Inc, with an inspection on September 25, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Medline Industries Inc
- Inspection Date
- September 25, 2009
- Product Type
- Devices
View Company Profile
ID · fd1c688c-dddb-44d9-b8f5-cd1330a5c127
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 614934
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
9- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 820.40Lack of procedures, or not maintained
- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.198(a)Complaint Handling Procedure
- 21 CFR 211.67(b)(2)Cleaning SOPs/schedules
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.70(a)(1)Process control instructions
- 21 CFR 211.80(a)Procedures To Be in Writing
- 21 CFR 211.100(b)SOPs not followed / documented
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Medline Industries Inc
4| Date | Classification | Office | Project area |
|---|---|---|---|
| March 11, 2015 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| August 2, 2013 | VAI | Center for Devices and Radiological Health | Project Evaluation: Devices |
| June 21, 2012 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| July 20, 2011 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Medline Industries Inc
- FDA Inspection 913527 - 2015-03-11
- FDA Inspection 842504 - 2013-08-02
- FDA Inspection 791750 - 2012-06-21
- FDA Inspection 739871 - 2011-07-20
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