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Sunday, December 22, 2024

FDA: 3 companies in cities within Miami-Dade County received 14 citations in April

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Namandjé N. Bumpus Principal Deputy Commissioner at U.S. Food And Drug Administration (fda) | Official website

Namandjé N. Bumpus Principal Deputy Commissioner at U.S. Food And Drug Administration (fda) | Official website

There were three companies in a city associated with Miami-Dade County that received FDA citations as a result of three inspections conducted in the county in April, 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 specifications established to ensure the quality of the dietary supplement.
  • You did not establish written procedures for quality control operations.
  • Your quality control personnel did not approve or reject specifications that may affect the identity, purity, strength, or composition of a dietary supplement.

Most of the companies cited were involved in the Devices sector.

All of the 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.

Companies located within Miami-Dade County Cities and the citations they received in April
Company NameArea of BusinessInspection DateIssue Cited
Efficient Laboratories, Inc.Food and Cosmetics04/25/2024Specifications met - quality
Efficient Laboratories, Inc.Food and Cosmetics04/25/2024Written procedures - quality control operations
Efficient Laboratories, Inc.Food and Cosmetics04/25/2024Processes, specifications, written procedures
Efficient Laboratories, Inc.Food and Cosmetics04/25/2024Quality control - supplier qualification
Efficient Laboratories, Inc.Food and Cosmetics04/25/2024Quality control - batch, product specifications
Medas, Inc.Devices04/26/2024Procedures not adequately established or maintained
Medas, Inc.Devices04/26/2024Lack of or inadequate procedures
Medas, Inc.Devices04/26/2024Lack of or inadequate procedures for storage.
Medas, Inc.Devices04/26/2024Lack of or inadequate complaint procedures
Skeletal Dynamics, Inc.Devices04/05/2024Not approved or obsolete document retrieval
Skeletal Dynamics, Inc.Devices04/05/2024Purchasing controls, Lack of or inadequate procedures
Skeletal Dynamics, Inc.Devices04/05/2024Maintenance schedule, Lack of or inadequate schedule
Skeletal Dynamics, Inc.Devices04/05/2024Lack of or inadequate receiving acceptance procedures
Skeletal Dynamics, Inc.Devices04/05/2024Lack of or inadequate DHR procedures

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