Company
United StatesSpectrum Medical Inc, Fort Mill, SC – FDA Inspections
Inspection records and compliance data for Spectrum Medical Inc in Fort Mill, South Carolina. 2 FDA inspections on record, last inspected May 24, 2024.
Company Profile
This profile covers Spectrum Medical Inc based in Fort Mill, South Carolina, United States.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 1
- NAI
- 1
- Form 483s
- 0
- Warning letters
- 0
First inspected October 28, 2019. Last inspected May 24, 2024.
Most cited issue areas
- Individual Report of Malfunction1 inspection
- Lack of or inadequate complaint procedures1 inspection
- Procedures not adequately established or maintained1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| May 24, 2024 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1240334 |
| October 28, 2019 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1110464 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Spectrum Medical Inc
FEI Number
3006126428
Address
481 Munn Rd Ste 250, Fort Mill, South Carolina 29715, United States
Country
United States
ID: 141efa1b-7402-4167-9f3b-4d8f436ef2bc