Suffolk Reporter

There were two companies in cities associated with Suffolk County that received FDA citations as a result of two inspections conducted in the county in March, 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:

• You did not determine whether you met established product specifications for identity and composition of the finished batch of the dietary supplement.
• You did not conduct at least one appropriate test or examination to verify the identity of a dietary ingredient, prior to its use.
• Acidified food is not manufactured in accordance with the scheduled process.

Both companies cited were involved in the Food and Cosmetics sector.

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
Elwood International, Inc.	Food and Cosmetics	03/08/2024	Scheduled process
Elwood International, Inc.	Food and Cosmetics	03/08/2024	Visible code
Elwood International, Inc.	Food and Cosmetics	03/08/2024	Raw materials, packaging, finished product
Elwood International, Inc.	Food and Cosmetics	03/08/2024	Maintenance of processing and production records
Elwood International, Inc.	Food and Cosmetics	03/08/2024	Processing and production - required information
Elwood International, Inc.	Food and Cosmetics	03/08/2024	Personnel
Elwood International, Inc.	Food and Cosmetics	03/08/2024	Plant construction and design
Elwood International, Inc.	Food and Cosmetics	03/08/2024	Pest control
Elwood International, Inc.	Food and Cosmetics	03/08/2024	Hazard analysis - Identification of hazard
Elwood International, Inc.	Food and Cosmetics	03/08/2024	Allergen preventive controls - Implement
Elwood International, Inc.	Food and Cosmetics	03/08/2024	Sanitation preventive controls - Implement
Elwood International, Inc.	Food and Cosmetics	03/08/2024	Process preventive controls - Appropriate (Adequate)
Elwood International, Inc.	Food and Cosmetics	03/08/2024	Sanitation preventive controls - Appropriate (Adequate)
Elwood International, Inc.	Food and Cosmetics	03/08/2024	Supply-chain program - Assurance (Adequate)
The Bountiful Company	Food and Cosmetics	03/18/2024	Specifications met - identity, purity, strength, composition
The Bountiful Company	Food and Cosmetics	03/18/2024	Component - verify identity, dietary ingredient