Company
United StatesECA Medical Instrurments, Newbury Park, CA – FDA Inspections
Inspection records and compliance data for ECA Medical Instrurments in Newbury Park, California. 1 FDA inspection on record, 1 Form 483, last inspected April 07, 2017.
Company Profile
This profile covers ECA Medical Instrurments based in Newbury Park, California, United States.
FDA Inspection History
- FDA inspections
- 1
- OAI
- 0
- VAI
- 1
- NAI
- 0
- Form 483s
- 1
- Warning letters
- 0
Inspected April 7, 2017.
Most cited issue areas
- Lack of or inadequate process validation1 inspection
- Lack of Written MDR Procedures1 inspection
FDA inspections (1)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| April 7, 2017 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1008945 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
ECA Medical Instrurments
FEI Number
3010052483
Address
1107 Tourmaline Dr, Newbury Park, California 91320, United States
Country
United States
ID: 4af6468b-9b62-45fc-a279-3e7741169fda