POINT Biopharma USA Inc.
Form 483 issued June 7, 2024 · Indianapolis, Indiana
- Observations
- 1
- Pages
- 2
- FEI number
- 3017226344
In short: On June 7, 2024, FDA issued a Form 483 with 1 observation to POINT Biopharma USA Inc. in Indianapolis, Indiana (FEI 3017226344). 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
1 of 1 observations on this 483 concern 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
Your firm failed to test samples of each component for identity and conformity with all appropriate…
This inspection in context
Questions about this 483
What did FDA find at POINT Biopharma USA Inc.?
FDA listed 1 observation 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 POINT Biopharma USA Inc. inspected by FDA?
This Form 483 is dated June 7, 2024.
How do I get the full Form 483 for POINT Biopharma USA Inc.?
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.