BWXT Medical Ltd.
Form 483 issued February 23, 2024 · Vancouver, Canada
- Inspection
- Feb 23, 2024
- Investigator
- Jose M. Cayuela
- Observations
- 1
- Pages
- 1
- FEI number
- 3004005970
In short: On February 23, 2024, FDA issued a Form 483 with 1 observation to BWXT Medical Ltd. in Vancouver, British Columbia (FEI 3004005970) after an inspection that ran Feb 23, 2024. The investigator was Jose M. Cayuela. Most observations concern packaging & labeling; the most-cited regulation is 21 CFR 211.130 (packaging and labeling operations).
At a glance
1 of 1 observations on this 483 concern packaging & labeling.
Most cited: 21 CFR 211.130 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures designed to assure that correct labels are used for…
This inspection in context
Jose M. Cayuela
23 documents · 2012–2025
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in India.
The firmBWXT Medical 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 211.130
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at BWXT Medical Ltd.?
FDA listed 1 observation on this Form 483, mostly about packaging & labeling. The most-cited regulation is 21 CFR 211.130 (packaging and labeling operations). The opening words of each observation are shown on this page.
Who inspected BWXT Medical Ltd.?
Jose M. Cayuela is named on this Form 483, for the inspection of Feb 23, 2024. Each investigator has a profile showing what they cite most.
When was BWXT Medical Ltd. inspected by FDA?
The inspection ran Feb 23, 2024, and the Form 483 is dated February 23, 2024.
How do I get the full Form 483 for BWXT Medical 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.