BWXT Medical Ltd.
Form 483 issued January 28, 2022 · Vancouver, Canada
- Inspection
- Jan 20 – Jan 28, 2022
- Investigator
- Teresa I. Navas
- Observations
- 5
- Pages
- 4
- FEI number
- 3004005970
In short: On January 28, 2022, FDA issued a Form 483 with 5 observations to BWXT Medical Ltd. in Vancouver, British Columbia (FEI 3004005970) after an inspection that ran Jan 20 – Jan 28, 2022. The investigator was Teresa I. Navas. Most observations concern facilities & equipment and quality system.
At a glance
3 of 5 observations on this 483 concern facilities & equipment.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Equipment and utensils are not cleaned, maintained and sanitized at appropriate intervals to prevent malfunctions and…
- 02
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate…
- 03
The responsibilities and procedures applicable to the quality control unit…
- 04
Employees are not given training in the particular operations they perform as…
This inspection in context
Teresa I. Navas
21 documents · 2020–2024
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 211.67
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at BWXT Medical Ltd.?
FDA listed 5 observations on this Form 483, mostly about facilities & equipment and quality system. The opening words of each observation are shown on this page.
Who inspected BWXT Medical Ltd.?
Teresa I. Navas is named on this Form 483, for the inspection of Jan 20 – Jan 28, 2022. Each investigator has a profile showing what they cite most.
When was BWXT Medical Ltd. inspected by FDA?
The inspection ran Jan 20 – Jan 28, 2022, and the Form 483 is dated January 28, 2022.
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.