FDA Inspection 1268708 - Osmotica Pharmaceutical US LLC - May 02, 2025

View on Dashboard

Discuss this record with AI

ChatGPT

Claude

Perplexity

Grok

Copilot

Document or profile

One record shows the event. A profile shows the pattern.

Buy this document for the source file and details behind this single event.

Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.

Explore Osmotica Pharmaceutical US LLC

Record Details

This FDA Inspection record concerns Osmotica Pharmaceutical US LLC, with an inspection on May 2, 2025, issued by the Atlanta District Office, covering human drugs.

Company: Osmotica Pharmaceutical US LLC
Inspection Date: May 2, 2025
Product Type: Human Drugs
Office: Atlanta District Office

Open in Dashboard

ID · bcd0928c-95f3-424a-ba3c-e4700c64ce58

Violation Codes6

21 CFR 211.100(a)21 CFR 211.100(b)21 CFR 211.198(a)21 CFR 211.22(d)21 CFR 211.25(a)21 CFR 211.67(b)

Full citation text and observation details available on the Dashboard.