FDA Inspection
MDF Instrumnets Medifriend IncMDF Instrumnets Medifriend Inc – FDA Inspection, Mar 27, 2009
Record Details
This FDA Inspection record concerns MDF Instrumnets Medifriend Inc, with an inspection on March 27, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- March 27, 2009
- Product Type
- Devices
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ID · 2294a4ef-0afd-484c-8a39-931ccbbfb819
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 586600
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
13- 21 CFR 820.70(c)Environmental control Lack of or inadequate procedures
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.198(a)(3)Processing MDRs {see also 803, 804}
- 21 CFR 820.40Lack of procedures, or not maintained
- 21 CFR 820.25(b)Training
- 21 CFR 820.22Quality audits - auditor independence
- 21 CFR 820.20Management responsibility
- 21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
- 21 CFR 820.30(e)Design review procedures - personnel
- 21 CFR 820.22Quality Audits - defined intervals
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Other FDA inspections of MDF Instrumnets Medifriend Inc
1| Date | Classification | Office | Project area |
|---|---|---|---|
| March 2, 2018 | Not classified | Office of Inspections and Investigations |
Other documents for MDF Instrumnets Medifriend Inc
- FDA Inspection 1048162 - 2018-03-02
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