Warren-Clinton News

There were two companies in a city associated with Clinton County that received FDA citations as a result of two inspections conducted in the county throughout 2023, according to reports from the U.S. Food and Drug Administration (FDA).

This is an increase over the number of companies cited in the previous year.

The citations in the county include:

• The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.
• Employees are not given training in the particular operations they perform as part of their function.
• Failure to maintain a backup file of data entered into the computer or related system.

The companies cited were involved in either Drugs or Devices sectors.

Both 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
Alkermes, Inc.	Drugs	10/19/2023	Procedures not in writing, fully followed
Alkermes, Inc.	Drugs	10/19/2023	Training--operations, GMPs, written procedures
Alkermes, Inc.	Drugs	10/19/2023	Backup file not maintained
Alkermes, Inc.	Drugs	10/19/2023	Computer control of master formula records
Alkermes, Inc.	Drugs	10/19/2023	Validation lacking for sterile drug products
Alkermes, Inc.	Drugs	10/19/2023	Scientifically sound laboratory controls
Alkermes, Inc.	Drugs	10/19/2023	Complaints reviewed by Quality Control Unit
Ferno-Washington, Inc.	Devices	01/24/2023	Evaluation of suppliers, contractors, etc., requirements
Ferno-Washington, Inc.	Devices	01/24/2023	Lack of or inadequate process validation
Ferno-Washington, Inc.	Devices	01/24/2023	Lack of or inadequate receiving acceptance procedures
Ferno-Washington, Inc.	Devices	01/24/2023	Nonconforming product, Lack of or inadequate procedures
Ferno-Washington, Inc.	Devices	01/24/2023	Lack of or inadequate procedures
Ferno-Washington, Inc.	Devices	01/24/2023	Investigation of device failures