North Baltimore Journal

There was one company in a city associated with Baltimore County that received FDA citations as a result of one inspection conducted in the county in May, according to reports from the U.S. Food and Drug Administration (FDA).

This is an increase over the number of companies cited in the previous month.

The citations in the county include:

• The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.
• Procedures for the cleaning and maintenance of equipment are deficient regarding sufficient detail of the methods, equipment, and materials used in the cleaning and maintenance operation, and the methods of disassembly and reassembling equipment as necessary to assure proper cleaning and maintenance.
• Your firm failed to establish written procedures for production and process controls designed to assure that the drug products have the identity, strength, purity, and quality that they are purported or represented to possess.

The company cited should take a voluntary action to correct its managing operations.

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
Warner Graham, LLP	Drugs	05/21/2024	Procedures not in writing, fully followed
Warner Graham, LLP	Drugs	05/21/2024	Cleaning SOPs/instructions
Warner Graham, LLP	Drugs	05/21/2024	Absence of Written Procedures
Warner Graham, LLP	Drugs	05/21/2024	Procedures for non-sterile drug products
Warner Graham, LLP	Drugs	05/21/2024	Lack of written stability program
Warner Graham, LLP	Drugs	05/21/2024	Complete instructions, procedures, specifications et. al.