Company
United StatesEmmy Medical, LLC, Weston, MA – FDA Inspections
Inspection records and compliance data for Emmy Medical, LLC in Weston, Massachusetts. 2 FDA inspections on record, last inspected April 18, 2019.
Company Profile
This profile covers Emmy Medical, LLC based in Weston, Massachusetts, United States.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 1
- NAI
- 1
- Form 483s
- 0
- Warning letters
- 0
First inspected February 9, 2016. Last inspected April 18, 2019.
Most cited issue areas
- Design changes - Lack of or Inadequate Procedures1 inspection
- Design validation- Lack of or inadequate procedures1 inspection
- Design verification - Lack of or inadequate procedures1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| April 18, 2019 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1088141 |
| February 9, 2016 | VAI | Medical Devices & Rad Health · Compliance: Devices | 960349 |
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
Emmy Medical, LLC
FEI Number
3010314836
Address
84 Byron Rd, Weston, Massachusetts 02493-2273, United States
Country
United States
ID: dfd914a9-474c-4813-88f1-7cda79a3fb0c