Minneapolis Review

There were five companies in cities associated with Hennepin County that received FDA citations as a result of five inspections conducted in the county in February, 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 month.

Of the eight 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
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
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