fda_483 · inspection_citation · high

Nephron Sc Inc -- FDA 483: 6 observations (2025-08-22)

Event date
2025-08-22 00:00:00Z
Observed
2026-07-12 22:31:57Z
Source ID
3010892830-2025-08-22-188822
Payload hash
8ecf6fda3f6675a2642498e8

Summary

Observation 1: Procedures designed to prevent microbiologica l contamination of drug products pu rporti ng to be steri le are not established and written. 5038 Outsourcing Facility Specifically, A. Yo...

Informational only. Not legal, financial, or medical advice.