Veganic SKN Limited
Form 483 issued July 21, 2025 · Rocklea, Australia
- Inspection
- Jul 15 – Jul 21, 2025
- Investigator
- Nibin Varghese
- Observations
- 6
- Pages
- 5
- FEI number
- 3024609429
In short: On July 21, 2025, FDA issued a Form 483 with 6 observations to Veganic SKN Limited in Rocklea, Queensland (FEI 3024609429) after an inspection that ran Jul 15 – Jul 21, 2025. The investigator was Nibin Varghese. Most observations concern quality system and laboratory controls; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
Observations span 4 systems, led by quality system.
Most cited: 21 CFR 211.22 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The responsibilities and procedures applicable to the quality control unit…
- 02
The quality control unit lacks the responsibility and authority to approve…
- 03
Laboratory controls shall include the establishment of scientifically sound and appropriate specifications, standards, sampling plans, and…
- 04
Specific identification tests are not conducted on components that have been accepted based on the…
This inspection in context
Nibin Varghese
14 documents · 2021–2026
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in Illinois.
The firmVeganic SKN Limited history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.22
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Veganic SKN Limited?
FDA listed 6 observations on this Form 483, mostly about quality system, laboratory controls and materials. The most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit). The opening words of each observation are shown on this page.
Who inspected Veganic SKN Limited?
Nibin Varghese is named on this Form 483, for the inspection of Jul 15 – Jul 21, 2025. Each investigator has a profile showing what they cite most.
When was Veganic SKN Limited inspected by FDA?
The inspection ran Jul 15 – Jul 21, 2025, and the Form 483 is dated July 21, 2025.
How do I get the full Form 483 for Veganic SKN Limited?
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.