Eosera, Inc.April 28, 2025

FDA 483 - Eosera, Inc. - April 28, 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 Eosera, Inc.

Record Details

Eosera, Inc., an OTC drug manufacturer in Fort Worth, TX, received a Form 483 with two observations during an FDA inspection. The firm was cited for failing to adequately follow quality control unit procedures regarding changes to operations and for not establishing written cleaning validation procedures for manufacturing equipment. These issues indicate deficiencies in the firm's quality system and equipment maintenance practices.

Company: Eosera, Inc.
Inspection Date: April 28, 2025
Product Type: Drugs
Office: Division of Human and Animal Food Operations - West III
Person: Kevin T. Nguyen (investigator)

Open in Dashboard

ID · 4b27806f-0243-4ab2-bea7-648c2df4130f