Company
Czech RepublicElla CS, SRO, Hradec Kralove 6, Czech Republic – FDA Inspections
Inspection records and compliance data for Ella CS, SRO in Hradec Kralove 6. 2 FDA inspections on record, last inspected May 31, 2018.
Company Profile
This profile covers Ella CS, SRO based in Hradec Kralove 6, Czech Republic.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 1
- NAI
- 1
- Form 483s
- 0
- Warning letters
- 0
First inspected March 12, 2015. Last inspected May 31, 2018.
Most cited issue areas
- Contamination control, Lack of or inadequate procedures1 inspection
- Lack of or inadequate receiving acceptance procedures1 inspection
- Supplier oversight1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| May 31, 2018 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1058595 |
| March 12, 2015 | VAI | Medical Devices & Rad Health · Compliance: Devices | 921071 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Ella CS, SRO
FEI Number
3004070722
Address
Milady Horakove 504/45, Hradec Kralove 6, Czech Republic
Country
Czech Republic
ID: ac1d1f8b-fb02-4f53-884e-de409e23e0b1