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Thursday, November 21, 2024

FDA: 1 company in cities within Cumberland County received 13 citations in April

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Robert M. Califf, M.D. Commissioner of Food and Drugs - FDA | Official Website

Robert M. Califf, M.D. Commissioner of Food and Drugs - FDA | Official Website

There was one company in a city associated with Cumberland County that received FDA citations as a result of one inspection conducted in the county in April, 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:

  • You did not establish an identity specification for each component.
  • You did not establish component specifications for purity and strength.
  • You did not establish product specifications for the of the finished dietary supplement.

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 Cumberland County Cities and the citations they received in April
Company NameArea of BusinessInspection DateIssue Cited
BodyBio, Inc.Food and Cosmetics04/26/2024Specifications - component identity
BodyBio, Inc.Food and Cosmetics04/26/2024Specifications-component purity, strength, composition
BodyBio, Inc.Food and Cosmetics04/26/2024Specifications - identity, purity, strength, composition
BodyBio, Inc.Food and Cosmetics04/26/2024Documentation - qualify supplier
BodyBio, Inc.Food and Cosmetics04/26/2024Re-confirm certificate of analysis
BodyBio, Inc.Food and Cosmetics04/26/2024Quality control operations - equipment records
BodyBio, Inc.Food and Cosmetics04/26/2024Master manufacturing record - each batch
BodyBio, Inc.Food and Cosmetics04/26/2024Batch record - date, time; maintenance
BodyBio, Inc.Food and Cosmetics04/26/2024Batch record - yield
BodyBio, Inc.Food and Cosmetics04/26/2024Examination, testing; appropriate
BodyBio, Inc.Food and Cosmetics04/26/2024Manufacturing history
BodyBio, Inc.Food and Cosmetics04/26/2024Clean, sanitize - filling, packaging equipment
BodyBio, Inc.Food and Cosmetics04/26/2024Product complaint - quality control investigate

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