Higley Industries, Inc.September 21, 2023

FDA 483 - Higley Industries, Inc. - September 21, 2023

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 Higley Industries, Inc.

Record Details

An FDA inspection of Higley Industries Inc in Dyersville, IA, a contract manufacturer of hand sanitizer, revealed significant deficiencies across multiple areas of its quality system. The firm lacked adequate controls for production records, raw material testing, laboratory operations, equipment maintenance, and quality unit oversight. These issues indicate a systemic failure to adhere to current Good Manufacturing Practices for drug products.

Company: Higley Industries, Inc.
Inspection Date: September 21, 2023
Product Type: Drugs
Office: Division of Human and Animal Food Operations - West II
Person: Torrey M. Ward

Open in Dashboard

ID · e763d22a-7072-40fe-9f96-a6e90de71b2c