Nexus Pharmaceuticals, LLC
Form 483 issued January 20, 2023 · Pleasant Prarie, Wisconsin
- Inspection
- Jan 9 – Jan 20, 2023
- Observations
- 4
- Pages
- 4
- FEI number
- 3017912110
In short: On January 20, 2023, FDA issued a Form 483 with 4 observations to Nexus Pharmaceuticals, LLC in Pleasant Prarie, Wisconsin (FEI 3017912110) after an inspection that ran Jan 9 – Jan 20, 2023. Most observations concern materials and production.
At a glance
Materials and production account for 3 of 4 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Failure to handle and store components in a…
- 02
Certificates of testing of containers and closures are accepted in lieu of testing without establishing the…
- 03
There are no written procedures for production and process controls designed to assure that the drug…
- 04
Appropriate controls are not exercised over computers or related systems to assure that changes in master…
This inspection in context
Questions about this 483
What did FDA find at Nexus Pharmaceuticals, LLC?
FDA listed 4 observations on this Form 483, mostly about materials, production and facilities & equipment. The opening words of each observation are shown on this page.
When was Nexus Pharmaceuticals, LLC inspected by FDA?
The inspection ran Jan 9 – Jan 20, 2023, and the Form 483 is dated January 20, 2023.
How do I get the full Form 483 for Nexus Pharmaceuticals, LLC?
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.