Company
United StatesScandinavian Formulas, Inc., Sellersville, PA – FDA Inspections
Inspection records and compliance data for Scandinavian Formulas, Inc. in Sellersville, Pennsylvania. 4 FDA inspections on record, last inspected November 21, 2016.
Company Profile
This profile covers Scandinavian Formulas, Inc. based in Sellersville, Pennsylvania, United States.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 0
- VAI
- 2
- NAI
- 2
- Form 483s
- 0
- Warning letters
- 0
First inspected June 8, 2009. Last inspected November 21, 2016.
Most cited issue areas
- Design control - no procedures1 inspection
- Design verification - output does not meet input requirement1 inspection
- Lack of or inadequate complaint procedures1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| November 21, 2016 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 992913 |
| July 25, 2014 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 889678 |
| April 6, 2012 | VAI | Medical Devices & Rad Health · Compliance: Devices | 778518 |
| June 8, 2009 | VAI | Human Drugs, Medical Devices & Rad Health · Postmarket Assurance: Devices | 588181 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Christie Clinic
Tucson Medical Center Mammography
The Mary Imogene Bassett Hospital
Mayer Laboratories, Inc.
Therasage, LLC.
Synergetics Inc
KPH Consolidation, Inc. dba Kingwood Medical Center
University of Texas Health Science Center at Tyler
Smith & Nephew, Inc.
88th Med. Group DTS/ SGQQ Wright Patterson Med. Ctr
Company Information
Name
Scandinavian Formulas, Inc.
FEI Number
3003547663
Address
140 E Church St, Sellersville, Pennsylvania 18960, United States
Country
United States
ID: 49d18df5-1332-418b-ba10-b7ce70e8e58c