Company
MaltaKelix bio (Malta) Ltd., Hal Far, Birzebbuga, Malta – FDA Inspections
Inspection records and compliance data for Kelix bio (Malta) Ltd. in Hal Far, Birzebbuga. 3 FDA inspections on record, 2 Form 483s, last inspected December 16, 2022.
Company Profile
This profile covers Kelix bio (Malta) Ltd. based in Hal Far, Birzebbuga, Malta.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 3
- NAI
- 0
- Form 483s
- 2
- Warning letters
- 0
First inspected February 20, 2018. Last inspected December 16, 2022.
Most cited issue areas
- Absence of Written Procedures1 inspection
- Actual vs. theoretical yields not determined1 inspection
- Buildings not maintained in good state of repair1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| December 16, 2022 | VAI | Human Drugs · Drug Quality Assurance | 1192875 |
| May 3, 2019 | VAI | Human Drugs · Generic Drug Evaluation | 1089383 |
| February 20, 2018 | VAI | Human Drugs · Generic Drug Evaluation | 1041539 |
FDA documents
Form 483s (1)
People (1)
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Company Information
Name
Kelix bio (Malta) Ltd.
FEI Number
3013541978
Address
14 Kelix Bio (Malta) Ltd. Hf, Qasam Industrijali Hal Far, Hal Far, Birzebbuga, Malta
Country
Malta
ID: 3595e81b-9a31-4dcc-b529-e58034aabdf7