Vegewax Candleworx Ltd.
Form 483 issued October 19, 2023 · Concord, Canada
- Inspection
- Oct 16 – Oct 19, 2023
- Investigator
- Tekalign Wondimu
- Observations
- 5
- Pages
- 3
- FEI number
- 3005787511
In short: On October 19, 2023, FDA issued a Form 483 with 5 observations to Vegewax Candleworx Ltd. in Concord, Ontario (FEI 3005787511) after an inspection that ran Oct 16 – Oct 19, 2023. The investigator was Tekalign Wondimu. Most observations concern quality system and materials; the most-cited regulation is 21 CFR 211.84 (testing and approval or rejection of components, drug product containers, and closures).
At a glance
3 of 5 observations on this 483 concern quality system.
Most cited: 21 CFR 211.192 (2×)
What FDA observed
Preview: the opening words of each observation- 01
The responsibilities and procedures applicable to the quality control unit…
- 02
The identity of each component of a drug product is not verified by conducting at least…
- 03
Establishment of the reliability of the component supplier's report of analyses is deficient in that the…
- 04
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
This inspection in context
Tekalign Wondimu
12 documents · 2021–2026
Cites FDCA 501(a)(2)(A) (insanitary conditions) more than any other section. Most of their documents are for sites in Virginia.
The firmVegewax Candleworx Ltd. history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Vegewax Candleworx Ltd.?
FDA listed 5 observations on this Form 483, mostly about quality system and materials. The most-cited regulation is 21 CFR 211.84 (testing and approval or rejection of components, drug product containers, and closures). The opening words of each observation are shown on this page.
Who inspected Vegewax Candleworx Ltd.?
Tekalign Wondimu is named on this Form 483, for the inspection of Oct 16 – Oct 19, 2023. Each investigator has a profile showing what they cite most.
When was Vegewax Candleworx Ltd. inspected by FDA?
The inspection ran Oct 16 – Oct 19, 2023, and the Form 483 is dated October 19, 2023.
How do I get the full Form 483 for Vegewax Candleworx 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.