North Baltimore Journal

There were five companies in the City of Baltimore that received FDA citations as a result of five inspections conducted in the city over the fourth quarter of 2023, according to reports from the U.S. Food and Drug Administration (FDA).

This is a 400% increase over the number of companies cited in the previous quarter.

The citations in the city include:

• You did not have a written food safety plan.
• Your HACCP plan does not list the procedures for monitoring and frequency of monitoring at each critical control point to ensure compliance with the critical limit.
• Your HACCP plan lists verification procedures that have not been developed in accordance with 21 CFR 123.8(a) to ensure that your HACCP plan is adequate to control food safety hazards, and is being effectively implemented.

Most of the companies cited were involved in the Food and Cosmetics sector.

Of the companies cited, four should take voluntary actions to correct their managing operations (80%). Additionally, one company had to take regulatory and/or administrative actions (20%).

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
Aerosol and Liquid Packaging, Inc.	Drugs	12/18/2023	Lack of quality control unit
Aerosol and Liquid Packaging, Inc.	Drugs	12/18/2023	Training--operations, GMPs, written procedures
Aerosol and Liquid Packaging, Inc.	Drugs	12/18/2023	Cleaning / Sanitizing / Maintenance
Aerosol and Liquid Packaging, Inc.	Drugs	12/18/2023	Calibration/Inspection/Checking not done
Aerosol and Liquid Packaging, Inc.	Drugs	12/18/2023	Reports of Analysis (Components)
Aerosol and Liquid Packaging, Inc.	Drugs	12/18/2023	Rejecting When Specifications Not Met
Aerosol and Liquid Packaging, Inc.	Drugs	12/18/2023	Absence of Written Procedures
Aerosol and Liquid Packaging, Inc.	Drugs	12/18/2023	Procedures for non-sterile drug products
Aerosol and Liquid Packaging, Inc.	Drugs	12/18/2023	Written records kept in individual logs
Aerosol and Liquid Packaging, Inc.	Drugs	12/18/2023	Accurate reproduction
BMORE Food, Inc.	Food and Cosmetics	12/06/2023	Food safety plan
BMORE Food, Inc.	Food and Cosmetics	12/06/2023	Monitoring - none
BMORE Food, Inc.	Food and Cosmetics	12/06/2023	Verification procedures - adequacy
BMORE Food, Inc.	Food and Cosmetics	12/06/2023	Signed and dated
BMORE Food, Inc.	Food and Cosmetics	12/06/2023	Calibration - adequacy
Food Opportunity, LLC	Food and Cosmetics	10/27/2023	Personnel
Food Opportunity, LLC	Food and Cosmetics	10/27/2023	Sanitary operations - Plant sanitation
Greater Baltimore Medical Center	Biologics	10/26/2023	Equipment observed, standardized, calibrated
Greater Baltimore Medical Center	Biologics	10/26/2023	SOPs for investigations, records
Healthy Spirit, LLC	Devices	11/03/2023	Design control - no procedures
Healthy Spirit, LLC	Devices	11/03/2023	Approval, inadequate purchasing data
Healthy Spirit, LLC	Devices	11/03/2023	Nonconforming product, Lack of or inadequate procedures
Healthy Spirit, LLC	Devices	11/03/2023	Lack of or inadequate procedures
Healthy Spirit, LLC	Devices	11/03/2023	Lack of or inadequate instructions
Healthy Spirit, LLC	Devices	11/03/2023	Lack of or inadequate complaint procedures
Healthy Spirit, LLC	Devices	11/03/2023	Servicing - Lack of or inadequate procedures