Minneapolis Review

There were seven companies in cities associated with Hennepin County that received FDA citations as a result of seven inspections conducted in the county over the first quarter of 2024, according to reports from the U.S. Food and Drug Administration (FDA).

This is a 16.7% increase over the number of companies cited in the previous quarter.

Of the 18 citations issued, the most common citation was 'Procedures for corrective and preventive action have not been adequately established'.

Most of the companies cited were involved in the Devices sector.

All of the companies cited should take voluntary actions to correct their 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
Chitogen, Inc.	Devices	03/19/2024	Documentation
Chitogen, Inc.	Devices	03/19/2024	Lack of or inadequate procedures
Creganna Medical	Devices	02/22/2024	Training - Lack of or inadequate procedures
Desserts by Alighieri, Inc.	Food and Cosmetics	02/09/2024	Manufacturing, processing, packing, holding - Controls
Great Ciao, Inc.	Food and Cosmetics	02/16/2024	Importer verification
Medspira, LLC	Devices	01/16/2024	Lack of System for Event Evaluations
Medspira, LLC	Devices	01/16/2024	Design plans - Lack of or inadequate
Medspira, LLC	Devices	01/16/2024	Design validation - Risk analysis
Medspira, LLC	Devices	01/16/2024	Design changes - Lack of or Inadequate Procedures
Medspira, LLC	Devices	01/16/2024	Design history file
Medspira, LLC	Devices	01/16/2024	Nonconforming product, Lack of or inadequate procedures
Medspira, LLC	Devices	01/16/2024	Lack of or inadequate procedures
Medspira, LLC	Devices	01/16/2024	Lack of or inadequate complaint procedures
P. M. T. Corporation	Devices	02/15/2024	Design Validation - Risk analysis not performed/inadequate
P. M. T. Corporation	Devices	02/15/2024	Calibration, Inspection, etc. Procedures Lack of or Inadequ
P. M. T. Corporation	Devices	02/15/2024	Lack of or inadequate procedures
P. M. T. Corporation	Devices	02/15/2024	Investigation of device failures
ProMed Pharma, LLC	Devices	02/21/2024	Lack of or inadequate procedures