Kelix bio (Malta) Ltd.
FDA inspection history in BIRZEBBUGIA, Malta, 2022
- 1
- Form 483
Every document, by year
- Form 483
2022: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2022One Form 483, at BIRZEBBUGIA, Malta.
Cited most
Across all Kelix bio (Malta) observations on file
- 21 CFR 211.160(a)General requirements1
- 21 CFR 211.192Production record review1
- 21 CFR 211.42(c)(10)(v)Design and construction features1
- 21 CFR 211.63Equipment design, size, and location1
The complete Kelix bio (Malta) file.
All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.
Sites
BIRZEBBUGIA, Malta
One Form 483 · 2022 · 4 observations
Latest: Form 483, Dec 16, 2022 →
Documents
1 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2022-12-16 | 483 Form 483 | BIRZEBBUGIA, Malta | 4 | $99 |
Investigators on these documents
FEI number 3013541978 · most recent document Dec 16, 2022
About Kelix bio (Malta) Ltd.
How many FDA Form 483s has Kelix bio (Malta) Ltd. received?
FDA Intel has 1 Form 483 on file for Kelix bio (Malta) Ltd.; the most recent is dated Dec 16, 2022.
When was Kelix bio (Malta) Ltd. last inspected by FDA?
The most recent FDA inspection document on file for Kelix bio (Malta) Ltd. is a Form 483 dated Dec 16, 2022, for the site in BIRZEBBUGIA, Malta.
What did FDA cite at Kelix bio (Malta) Ltd.?
The regulations cited most in the observations on file for Kelix bio (Malta) Ltd. are 21 CFR 211.160(a) (General requirements), 1 time; 21 CFR 211.192 (Production record review), 1 time; 21 CFR 211.42(c)(10)(v) (Design and construction features), 1 time.