FDA Inspection
PFM MEDICAL INC.PFM MEDICAL INC. – FDA Inspection, Sep 14, 2014
Record Details
This FDA Inspection record concerns PFM MEDICAL INC., with an inspection on September 14, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- PFM MEDICAL INC.
- Inspection Date
- September 14, 2014
- Product Type
- Devices
View Company Profile
ID · c1659438-4bf8-46b3-bd8e-d04de9683751
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 899251
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 820.100(b)Documentation
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.50(a)Evaluation of suppliers, contractors, etc., requirements
Full citation text and observation details available on the Dashboard.
Other FDA inspections of PFM MEDICAL INC.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| November 2, 2018 | Not classified | Los Angeles District Office | |
| August 30, 2012 | VAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
| February 11, 2009 | NAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
Other documents for PFM MEDICAL INC.
- FDA Inspection 1108604 - 2018-11-02
- FDA Inspection 799317 - 2012-08-30
- FDA Inspection 565031 - 2009-02-11
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