Naples Standard

There was one company in a city associated with Collier County that received FDA citations as a result of one inspection conducted in the county over the first quarter of 2024, according to reports from the U.S. Food and Drug Administration (FDA).

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

The citations in the county include:

• Procedures to ensure equipment is routinely calibrated have not been adequately established.
• Procedures have not been adequately established to control product that does not conform to specified requirements.
• Procedures for corrective and preventive action have not been adequately established.

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.

Company Name	Area of Business	Inspection Date	Issue Cited
Summit Orthopedic Technologies, Inc.	Devices	02/15/2024	Calibration, Inspection, etc. Procedures Lack of or Inadequ
Summit Orthopedic Technologies, Inc.	Devices	02/15/2024	Nonconforming product, Lack of or inadequate procedures
Summit Orthopedic Technologies, Inc.	Devices	02/15/2024	Lack of or inadequate procedures
Summit Orthopedic Technologies, Inc.	Devices	02/15/2024	Review and evaluation for investigation