Company
SlovakiaEKOM spol. s.r.o., Piestany, Slovakia – FDA Inspections
Inspection records and compliance data for EKOM spol. s.r.o. in Piestany. 4 FDA inspections on record, 1 Form 483, last inspected May 28, 2026.
Company Profile
This profile covers EKOM spol. s.r.o. based in Piestany, Slovakia.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 0
- VAI
- 2
- NAI
- 1
- Unclassified
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected October 25, 2012. Last inspected May 28, 2026.
Most cited issue areas
- Corrective action procedures not documented1 inspection
- Design and development procedures not documented1 inspection
- Design review - Lack of or inadequate procedures1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| May 28, 2026 | Not classified | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1319224 |
| March 21, 2024 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1233666 |
| May 25, 2017 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1016985 |
| October 25, 2012 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 811214 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
EKOM spol. s.r.o.
FEI Number
3005245901
Address
Priemyselna 5031/18, Piestany, Slovakia
Country
Slovakia
ID: 2313a8b1-5ab5-44e9-bd98-9550e47e61eb