Company
United StatesSpectrum Plastics Group, Saint Louis Park, MN – FDA Inspections
Inspection records and compliance data for Spectrum Plastics Group in Saint Louis Park, Minnesota. 5 FDA inspections on record, 1 Form 483, last inspected December 19, 2019.
Company Profile
This profile covers Spectrum Plastics Group based in Saint Louis Park, Minnesota, United States.
FDA Inspection History
- FDA inspections
- 5
- OAI
- 0
- VAI
- 1
- NAI
- 4
- Form 483s
- 1
- Warning letters
- 0
First inspected March 4, 2009. Last inspected December 19, 2019.
Most cited issue areas
- Calibration, Inspection, etc. Procedures Lack of or Inadequ1 inspection
- Environmental control Lack of or inadequate procedures1 inspection
FDA inspections (5)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| December 19, 2019 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1116166 |
| October 3, 2016 | VAI | Medical Devices & Rad Health · Compliance: Devices | 987433 |
| August 20, 2014 | NAI | Medical Devices & Rad Health · Compliance: Devices | 891880 |
| November 2, 2011 | NAI | Medical Devices & Rad Health · Compliance: Devices | 752702 |
| March 4, 2009 | NAI | Medical Devices & Rad Health · Compliance: Devices | 566795 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Spectrum Plastics Group
FEI Number
1000115735
Address
7309 W 27th St, Saint Louis Park, Minnesota 55426, United States
Country
United States
ID: d75a1052-1a43-4d18-b79f-bb52ed8da6ff