fda_483 · inspection_citation · high

BPI Labs LLC -- FDA 483: 1 observation (2025-02-21)

Event date
2025-02-21 00:00:00Z
Observed
2026-07-12 22:32:30Z
Source ID
3015156709-2025-02-21-185637
Payload hash
b00c347c875efe4daaffb7a7

Summary

Observation 1: The labels of your outsourcing facility's drug products do not include information required by section 503B(a)(10)(A) of the Federal Food, Drug, and Cosmetic Act (FD&C Act). Specificall...

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