Overview
- 9 public-safe observations are available for this inspection.
- 7 structured CFR citations are represented.
- 2 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
20 Feb 2018
21 CFR 117.160(a)
Process Controls Validation Not Performed
Cited by Taichun Qin, Santos E Camara
20 Feb 2018
21 CFR 211.103
Actual vs. theoretical yields not determined
Cited by Taichun Qin, Santos E Camara
20 Feb 2018
21 CFR 211.113(b)
Procedures for sterile drug products
Cited by Taichun Qin, Santos E Camara
20 Feb 2018
21 CFR 211.113(b)
Validation lacking for sterile drug products
Cited by Taichun Qin, Santos E Camara
Inspected site
KBKelix bio (Malta) Ltd.Hal Far, Birzebbuga, Malta
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 117.160(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.103 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.58 | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 9 observations
The full inspection record, as Atlas holds it, so your team sees exactly what was cited and how it was answered.
- The site's full inspection history around this Form 483
- Whether these citations escalated to a warning letter
- The investigators involved and the citations they repeat elsewhere