BWXT Medical Ltd.
Form 483 issued March 3, 2023 · Ottawa, Canada
- Inspection
- Feb 27 – Mar 3, 2023
- Investigators
- Michele Gottshall· Truong X. Nguyen
- Observations
- 8
- Pages
- 5
- FEI number
- 3001092088
In short: On March 3, 2023, FDA issued a Form 483 with 8 observations to BWXT Medical Ltd. in Ottawa, Ontario (FEI 3001092088) after an inspection that ran Feb 27 – Mar 3, 2023. The investigators were Michele Gottshall and Truong X. Nguyen. Most observations concern production and materials; the most-cited regulation is 21 CFR 211.110 (sampling and testing of in-process materials and drug products).
At a glance
Production and materials account for 5 of 8 observations.
Most cited: 21 CFR 211.110 (2×) · 211.84 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Control procedures are not established which validate the performance of those manufacturing processes that may be…
- 02
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include…
- 03
Your in-process specifications for sampling and testing of in-process materials and drug products were not determined…
- 04
Establishment of the reliability of the component supplier's report of analyses is deficient in that the…
This inspection in context
Michele Gottshall
12 documents · 2020–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Pennsylvania.
The firmBWXT Medical Ltd. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.110
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at BWXT Medical Ltd.?
FDA listed 8 observations on this Form 483, mostly about production, materials and quality system. The most-cited regulation is 21 CFR 211.110 (sampling and testing of in-process materials and drug products). The opening words of each observation are shown on this page.
Who inspected BWXT Medical Ltd.?
Michele Gottshall and Truong X. Nguyen are named on this Form 483, for the inspection of Feb 27 – Mar 3, 2023. Each investigator has a profile showing what they cite most.
When was BWXT Medical Ltd. inspected by FDA?
The inspection ran Feb 27 – Mar 3, 2023, and the Form 483 is dated March 3, 2023.
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.