Company
United StatesSpectra Medical Devices, Llc, Wilmington, MA – FDA Inspections
Inspection records and compliance data for Spectra Medical Devices, Llc in Wilmington, Massachusetts. 3 FDA inspections on record, 1 Form 483, last inspected April 25, 2024.
Company Profile
This profile covers Spectra Medical Devices, Llc based in Wilmington, Massachusetts, United States.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 2
- NAI
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected May 4, 2012. Last inspected April 25, 2024.
Most cited issue areas
- Documentation2 inspections
- Complaints1 inspection
- Design review - documentation1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| April 25, 2024 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1237163 |
| March 30, 2017 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1007007 |
| May 4, 2012 | VAI | Human Drugs, Medical Devices & Rad Health · Drug Quality Assurance | 779912 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Spectra Medical Devices, Llc
FEI Number
3000204727
Address
299 Ballardvale St Ste 1, Wilmington, Massachusetts 01887, United States
Country
United States
ID: 26b1d6e1-5a34-438c-a935-dde37cfd3885