Lehigh Times

There were two companies in cities associated with Lehigh County that received FDA citations as a result of two inspections conducted in the county throughout 2023, according to reports from the U.S. Food and Drug Administration (FDA).

This is a 60% decrease from the number of companies cited in the previous year.

The citations in the county include:

• Your plant was not constructed and designed to facilitate maintenance and sanitary operations.
• You did not identify, hold and store a toxic chemical in a manner that protects against contamination.
• You did not exclude pests from your food plant to protect against contamination of food.

The companies cited were involved in either Food and Cosmetics or Drugs sectors.

Of the companies cited, one should take voluntary action to correct its managing operations (50%). Additionally, one company had to take regulatory and/or administrative actions (50%).

The FDA routinely inspects facilities across the nation to determine if the workplace and their products are compliant with FDA-regulated laws and regulations implemented to improve overall public health. Inspection results are then disclosed publicly.

The FDA is a government agency that is primarily responsible for monitoring the production and distribution of human and animal drugs, biological products, medical supplies and tobacco products for safety quality, according to its website.

Company Name	Area of Business	Inspection Date	Issue Cited
Central Admixture Pharmacy Services, Inc.	Drugs	03/30/2023	Computer control of master formula records
Central Admixture Pharmacy Services, Inc.	Drugs	03/30/2023	Procedures for non-sterile drug products
Central Admixture Pharmacy Services, Inc.	Drugs	03/30/2023	Scientifically sound laboratory controls
Central Admixture Pharmacy Services, Inc.	Drugs	03/30/2023	Sterility/pyrogen-free testing
Central Admixture Pharmacy Services, Inc.	Drugs	03/30/2023	Investigations of discrepancies, failures
Central Admixture Pharmacy Services, Inc.	Drugs	03/30/2023	Written record of investigation incomplete
Gallina Foods and Imports, Inc.	Food and Cosmetics	10/25/2023	Plant construction and design
Gallina Foods and Imports, Inc.	Food and Cosmetics	10/25/2023	Toxic chemicals - Identified, held, stored
Gallina Foods and Imports, Inc.	Food and Cosmetics	10/25/2023	Pest control
Gallina Foods and Imports, Inc.	Food and Cosmetics	10/25/2023	Sanitary facilities and controls
Gallina Foods and Imports, Inc.	Food and Cosmetics	10/25/2023	Raw materials and rework controls - Filth and contamination
Gallina Foods and Imports, Inc.	Food and Cosmetics	10/25/2023	Raw materials - Allergen identification
Gallina Foods and Imports, Inc.	Food and Cosmetics	10/25/2023	Manufacturing, processing, packing, holding - Controls