Company
Dominican Republic (the)AccuMED Corp., Nigua, Dominican Republic (the) – FDA Inspections
Inspection records and compliance data for AccuMED Corp. in Nigua. 3 FDA inspections on record, 1 Form 483, last inspected July 20, 2023.
Company Profile
This profile covers AccuMED Corp. based in Nigua, Dominican Republic (the).
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 2
- NAI
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected November 14, 2013. Last inspected July 20, 2023.
Most cited issue areas
- Lack of or inadequate process validation1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| July 20, 2023 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1214917 |
| May 25, 2017 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1021505 |
| November 14, 2013 | VAI | Medical Devices & Rad Health · Compliance: Devices | 859554 |
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
AccuMED Corp.
FEI Number
3007309299
Address
Zona Franca De Nigua, Building 6, Nigua, Dominican Republic (the)
Country
Dominican Republic (the)
ID: 77079d51-2c3d-455a-995c-92c13a78c39a