North Baltimore Journal

There were 14 companies in the City of Baltimore that received FDA citations as a result of 15 inspections conducted in the city throughout 2023, according to reports from the U.S. Food and Drug Administration (FDA).

This is a 75% increase over the number of companies cited in the previous year.

Of the 55 citations issued, the most common citation was 'You did not take a reasonable measure or precaution related to personnel practices'.

Most of the companies cited were involved in the Food and Cosmetics sector. The second most common type of company cited in the time period worked in the the Devices sector.

Of the companies cited, 12 should take voluntary actions to correct their managing operations (85.7%). Additionally, two companies had to take regulatory and/or administrative actions (14.3%).

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
American Hearth Emporium Bakery, LLC	Food and Cosmetics	06/07/2023	Manufacturing, processing, packing, holding - Controls
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
Casa di Pasta, Inc.	Food and Cosmetics	06/09/2023	Personnel
Casa di Pasta, Inc.	Food and Cosmetics	06/09/2023	HACCP plan implementation
Casa di Pasta, Inc.	Food and Cosmetics	06/09/2023	Ongoing verification - complaints, calibration records
Crevel Distribution, Inc.	Food and Cosmetics	06/23/2023	Toilet, hand washing facilities - water, soap, dryers
Crevel Distribution, Inc.	Food and Cosmetics	06/23/2023	Toilet, hand washing facilities - good repair, sanitary
DeBaufre Bakeries, Inc.	Food and Cosmetics	09/27/2023	Personnel
DeBaufre Bakeries, Inc.	Food and Cosmetics	09/27/2023	Pest control
DeBaufre Bakeries, Inc.	Food and Cosmetics	09/27/2023	Sanitation of food-contact surfaces - Frequency
DeBaufre Bakeries, Inc.	Food and Cosmetics	09/27/2023	Sanitation of non-food-contact surfaces - Manner and frequency
DeBaufre Bakeries, Inc.	Food and Cosmetics	09/27/2023	Raw materials - Allergen identification
DeBaufre Bakeries, Inc.	Food and Cosmetics	09/27/2023	Manufacturing, processing, packing, holding - Controls
Food Opportunity, LLC	Food and Cosmetics	10/27/2023	Personnel
Food Opportunity, LLC	Food and Cosmetics	10/27/2023	Sanitary operations - Plant sanitation
Fresh Ideation Food Group, LLC.	Food and Cosmetics	01/05/2023	Sanitation preventive controls - Implement
Fresh Ideation Food Group, LLC.	Food and Cosmetics	01/05/2023	Sanitation preventive controls - Appropriate (Adequate)
Fresh Ideation Food Group, LLC.	Food and Cosmetics	03/24/2023	Plant construction and design
Fresh Ideation Food Group, LLC.	Food and Cosmetics	03/24/2023	Sanitary operations - Plant sanitation
Fresh Ideation Food Group, LLC.	Food and Cosmetics	03/24/2023	Equipment and utensils - Design and maintenance
Fresh Ideation Food Group, LLC.	Food and Cosmetics	03/24/2023	Hazard analysis - Identification of hazard
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
Howard M. Richard, III, M.D.	Devices	03/06/2023	Investigator non-compliance with agreement/plan/regulations
Howard M. Richard, III, M.D.	Devices	03/06/2023	Investigator device accountability inadequate
Jet Blue Airlines	Food and Cosmetics	05/03/2023	Prevention of the spread of communicable diseases
Pack-It, LLC	Food and Cosmetics	04/19/2023	Personnel
Pack-It, LLC	Food and Cosmetics	04/19/2023	Sanitation of non-food-contact surfaces - Manner and frequency
ReConserve of Maryland, Inc.	Veterinary	06/29/2023	Grounds
ReConserve of Maryland, Inc.	Veterinary	06/29/2023	Outdoor Bulk Storage
ReConserve of Maryland, Inc.	Veterinary	06/29/2023	Raw Material Controls
ReConserve of Maryland, Inc.	Veterinary	06/29/2023	Hazard Analysis
ReConserve of Maryland, Inc.	Veterinary	06/29/2023	Preventive Controls
ReConserve of Maryland, Inc.	Veterinary	06/29/2023	Reanalysis of FSP