FDA issued 8 citations in cities across Hennepin County in January

James “Jim” Sigg FDA\'s Deputy Commissioner for Operations and Chief Operating Officer | Official Website

By Minneapolis Review

Feb 1, 2024

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

This is unchanged from the number of companies cited in the previous month.

The citations in the county include:

The written MDR Procedure does not include an internal system which provides for timely and effective identification, communication and evaluation of events that may be subject to medical device reporting requirements.
Design plans that describe or reference the design and development activities and define responsibility for implementation have not been adequately established.
Results of the design risk analysis were not adequately documented.

The company cited was involved in the Devices sector.

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.

Companies located within Hennepin County Cities and the citations they received in January

Company Name	Area of Business	Inspection Date	Issue Cited
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