Company
United StatesLena Cup, New York, NY – FDA Inspections
Inspection records and compliance data for Lena Cup in New York, New York. 1 FDA inspection on record, 1 Form 483, last inspected July 26, 2018.
Company Profile
This profile covers Lena Cup based in New York, New York, United States.
FDA Inspection History
- FDA inspections
- 1
- OAI
- 0
- VAI
- 1
- NAI
- 0
- Form 483s
- 1
- Warning letters
- 0
Inspected July 26, 2018.
Most cited issue areas
- Design control - no procedures1 inspection
- Evaluation of suppliers, contractors, etc., requirements1 inspection
- Investigation of device failures1 inspection
FDA inspections (1)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| July 26, 2018 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1060464 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Lena Cup
FEI Number
3011390138
Address
244 5th Ave # 2243, New York, New York 10001, United States
Country
United States
ID: 874a724a-97b1-41f6-b14a-c7172e01062d