Company
BulgariaFICOSOTA LTD, Shumen, Bulgaria – FDA Inspections
Inspection records and compliance data for FICOSOTA LTD in Shumen. 1 FDA inspection on record, 1 Form 483, last inspected September 05, 2019.
Company Profile
This profile covers FICOSOTA LTD based in Shumen, Bulgaria.
FDA Inspection History
- FDA inspections
- 1
- OAI
- 0
- VAI
- 0
- NAI
- 0
- Unclassified
- 1
- Form 483s
- 1
- Warning letters
- 0
Inspected September 5, 2019.
Most cited issue areas
- Absence of Written Procedures1 inspection
- Active ingredient retained sample kept1 inspection
- Annual visual exams of drug products1 inspection
FDA inspections (1)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| September 5, 2019 | Not classified | Human Drugs · Drug Quality Assurance | 1101635 |
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
FICOSOTA LTD
FEI Number
3014115921
Address
Madara Str. 48, Site 2, Shumen, Bulgaria
Country
Bulgaria
ID: 31181168-88d6-4b28-91b3-bac3f536b164