Nephron Pharmaceuticals
Form 483 issued December 2, 2022 · Kentucky
- Inspection
- Nov 8 – Dec 2, 2022
- Observations
- 4
- Pages
- 4
- FEI number
- 3010247115
In short: On December 2, 2022, FDA issued a Form 483 with 4 observations to Nephron Pharmaceuticals in Kentucky (FEI 3010247115) after an inspection that ran Nov 8 – Dec 2, 2022.
What FDA observed
Preview: the opening words of each observation- 01
There is no quality…
- 02
Reserve samples from representative sample lots or batches of drug products selected by acceptable statistical procedures…
- 03
Employees are not given training in written procedmes required by cummt…
- 04
Drug products are not stored under appropriate conditions of humidity and light so that their identity…
This inspection in context
Questions about this 483
What did FDA find at Nephron Pharmaceuticals?
FDA listed 4 observations on this Form 483. The opening words of each observation are shown on this page.
When was Nephron Pharmaceuticals inspected by FDA?
The inspection ran Nov 8 – Dec 2, 2022, and the Form 483 is dated December 2, 2022.
How do I get the full Form 483 for Nephron Pharmaceuticals?
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.