FDA Inspection
Specialized Medical Devices IncSpecialized Medical Devices Inc – FDA Inspection, May 7, 2010
Record Details
This FDA Inspection record concerns Specialized Medical Devices Inc, with an inspection on May 7, 2010, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- May 7, 2010
- Product Type
- Drugs
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ID · f837be1e-7440-4745-9a4a-59e0ad356f6c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 662425
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
7- 21 CFR 211.68(b)Written record not kept of program and validation data
- 21 CFR 211.100(a)Changes to Procedures Not Reviewed, Approved
- 21 CFR 211.192Quality control unit review of records
- 21 CFR 211.68(b)input/output verification
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.100(a)Approval and review of procedures
- 21 CFR 211.80(a)Written Procedures Not Followed
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Other FDA inspections of Specialized Medical Devices Inc
1| Date | Classification | Office | Project area |
|---|---|---|---|
| April 16, 2013 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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