Zochem ULC
Form 483 issued July 20, 2023 · Brampton, Canada
- Inspection
- Jul 17 – Jul 20, 2023
- Observations
- 2
- Pages
- 1
- FEI number
- 3000104256
In short: On July 20, 2023, FDA issued a Form 483 with 2 observations to Zochem ULC in Brampton, Ontario (FEI 3000104256) after an inspection that ran Jul 17 – Jul 20, 2023. Most observations concern 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
Observations span 1 system, led by materials.
Most cited: 21 CFR 211.84 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Reports of analysis from raw material suppliers are accepted in lieu of testing conformity with all…
- 02
Supplier qualification to approve a new supplier did not include all activities as outlined in…
This inspection in context
Questions about this 483
What did FDA find at Zochem ULC?
FDA listed 2 observations on this Form 483, mostly about 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.
When was Zochem ULC inspected by FDA?
The inspection ran Jul 17 – Jul 20, 2023, and the Form 483 is dated July 20, 2023.
How do I get the full Form 483 for Zochem ULC?
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.