Kelix bio (Malta) Ltd.
Form 483 issued December 16, 2022 · BIRZEBBUGIA, Malta
- Inspection
- Dec 8 – Dec 16, 2022
- Investigator
- William Leonard
- Observations
- 4
- Pages
- 2
- FEI number
- 3013541978
In short: On December 16, 2022, FDA issued a Form 483 with 4 observations to Kelix bio (Malta) Ltd. in BIRZEBBUGIA, HALFAR (FEI 3013541978) after an inspection that ran Dec 8 – Dec 16, 2022. The investigator was William Leonard. Most observations concern facilities & equipment and quality system.
At a glance
Facilities & equipment and quality system account for 3 of 4 observations.
What FDA observed
Preview: the opening words of each observation- 01
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 02
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate…
- 03
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room…
- 04
Established test procedures are not documented at…
This inspection in context
William Leonard
17 documents · 2015–2023
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in New York.
The firmKelix bio (Malta) Ltd. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Kelix bio (Malta) Ltd.?
FDA listed 4 observations on this Form 483, mostly about facilities & equipment, quality system and laboratory controls. The opening words of each observation are shown on this page.
Who inspected Kelix bio (Malta) Ltd.?
William Leonard is named on this Form 483, for the inspection of Dec 8 – Dec 16, 2022. Each investigator has a profile showing what they cite most.
When was Kelix bio (Malta) Ltd. inspected by FDA?
The inspection ran Dec 8 – Dec 16, 2022, and the Form 483 is dated December 16, 2022.
How do I get the full Form 483 for Kelix bio (Malta) Ltd.?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.