Company
United StatesPFM MEDICAL INC., Carlsbad, CA – FDA Inspections
Inspection records and compliance data for PFM MEDICAL INC. in Carlsbad, California. 4 FDA inspections on record, last inspected November 02, 2018.
Company Profile
This profile covers PFM MEDICAL INC. based in Carlsbad, California, United States.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 0
- VAI
- 2
- NAI
- 1
- Unclassified
- 1
- Form 483s
- 0
- Warning letters
- 0
First inspected February 11, 2009. Last inspected November 2, 2018.
Most cited issue areas
- Documentation1 inspection
- Evaluation of suppliers, contractors, etc., requirements1 inspection
- Nonconforming product, Lack of or inadequate procedures1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| November 2, 2018 | Not classified | Medical Devices & Rad Health | 1108604 |
| September 14, 2014 | VAI | Medical Devices & Rad Health · Compliance: Devices | 899251 |
| August 30, 2012 | VAI | Medical Devices & Rad Health · Bioresearch Monitoring | 799317 |
| February 11, 2009 | NAI | Medical Devices & Rad Health · Bioresearch Monitoring | 565031 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
PFM MEDICAL INC.
FEI Number
3013666218
Address
1916 Palomar Oaks Way, Carlsbad, California 92008, United States
Country
United States
ID: b84866ac-7bd6-4eb1-9a69-4a48a03ae913