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Suffolk Reporter

Friday, November 15, 2024

Companies across Suffolk County cities saw 11 FDA citations in July

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

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

There was one company in a city associated with Suffolk County that received FDA citations as a result of one inspection conducted in the county in July, 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 month.

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.

The company cited was involved in the Food and Cosmetics 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 Suffolk County Cities and the citations they received in July
Company NameArea of BusinessInspection DateIssue Cited
Country Life, LLCFood and Cosmetics07/12/2024Personnel - hygienic practices
Country Life, LLCFood and Cosmetics07/12/2024Specifications - component identity
Country Life, LLCFood and Cosmetics07/12/2024Specifications-component purity, strength, composition
Country Life, LLCFood and Cosmetics07/12/2024Specifications - contamination limits
Country Life, LLCFood and Cosmetics07/12/2024Specifications - identity, purity, strength, composition
Country Life, LLCFood and Cosmetics07/12/2024Tests, examinations - scientifically valid
Country Life, LLCFood and Cosmetics07/12/2024Master manufacturing record theoretical and expected yield
Country Life, LLCFood and Cosmetics07/12/2024Instructions; specifications; packaged, labeled
Country Life, LLCFood and Cosmetics07/12/2024Master manufacturing record - sampling, tests, examinations
Country Life, LLCFood and Cosmetics07/12/2024Batch record - initials; each step
Country Life, LLCFood and Cosmetics07/12/2024Hold - mix-up, contamination, deterioration

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