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 over the third quarter of 2024, according to reports from the U.S. Food and Drug Administration (FDA).

This is a 33.3% decrease from the number of companies cited in the previous quarter.

The citations in the county include:

• Your personnel did not use hygienic practices to the extent necessary to protect against contamination of components, dietary supplements, or contact surfaces.
• You did not establish an identity specification for each component.
• You did not establish component specifications for purity, strength and composition.

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
Country Life, LLC	Food and Cosmetics	07/12/2024	Personnel - hygienic practices
Country Life, LLC	Food and Cosmetics	07/12/2024	Specifications - component identity
Country Life, LLC	Food and Cosmetics	07/12/2024	Specifications-component purity, strength, composition
Country Life, LLC	Food and Cosmetics	07/12/2024	Specifications - contamination limits
Country Life, LLC	Food and Cosmetics	07/12/2024	Specifications - identity, purity, strength, composition
Country Life, LLC	Food and Cosmetics	07/12/2024	Tests, examinations - scientifically valid
Country Life, LLC	Food and Cosmetics	07/12/2024	Master manufacturing record theoretical and expected yield
Country Life, LLC	Food and Cosmetics	07/12/2024	Instructions; specifications; packaged, labeled
Country Life, LLC	Food and Cosmetics	07/12/2024	Master manufacturing record - sampling, tests, examinations
Country Life, LLC	Food and Cosmetics	07/12/2024	Batch record - initials; each step
Country Life, LLC	Food and Cosmetics	07/12/2024	Hold - mix-up, contamination, deterioration
Steinway Pasta & Gelati, Inc.	Food and Cosmetics	08/01/2024	Sanitary operations - Plant maintenance
Steinway Pasta & Gelati, Inc.	Food and Cosmetics	08/01/2024	Manufacturing, processing, packing, holding - Controls