Company
Dominican Republic (the)Covidien, San Isidro, Dominican Republic (the) – FDA Inspections
Inspection records and compliance data for Covidien in San Isidro. 4 FDA inspections on record (1 OAI), last inspected April 28, 2022.
Company Profile
This profile covers Covidien based in San Isidro, Dominican Republic (the).
FDA Inspection History
- FDA inspections
- 4
- OAI
- 1
- VAI
- 0
- NAI
- 3
- Form 483s
- 0
- Warning letters
- 0
First inspected August 17, 2011. Last inspected April 28, 2022.
Most cited issue areas
- Lack of or inadequate procedures - Acceptance activities1 inspection
- Lack of or inadequate process validation1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| April 28, 2022 | OAI | Medical Devices & Rad Health · Compliance: Devices | 1169814 |
| August 9, 2017 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1036260 |
| August 22, 2014 | NAI | Medical Devices & Rad Health · Compliance: Devices | 900524 |
| August 17, 2011 | NAI | Medical Devices & Rad Health · Compliance: Devices | 739627 |
FDA documents
Form 483s (1)
People (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Covidien
FEI Number
3003495548
Address
ZONA FRANCA DE SAN ISIDRO, Carretera San Isidro, Km 17, San Isidro, Dominican Republic (the)
Country
Dominican Republic (the)
ID: b19dc04e-0d0e-489f-94c0-d6d406d65a22