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Saturday, November 23, 2024

FDA: 2 companies in cities within Montgomery County received 8 citations in Q4 2023

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Hilary Marston, M.D., M.P.H. Chief Medical Officer (CMO) of the FDA | Official Website

Hilary Marston, M.D., M.P.H. Chief Medical Officer (CMO) of the FDA | Official Website

There were two companies in cities associated with Montgomery County that received FDA citations as a result of two inspections conducted in the county over the fourth quarter of 2023, according to reports from the U.S. Food and Drug Administration (FDA).

This is unchanged from the number of companies cited in the previous quarter.

The citations in the county include:

  • You did not identify and evaluate each known or reasonably foreseeable hazard for each type of animal food you manufacture, process, pack or hold in your facility.
  • You did not identify and implement preventive controls to ensure that any hazards requiring a preventive control are significantly minimized or prevented.
  • The corrective action you implemented was not appropriate.

Both companies cited were involved in either Veterinary or Devices sectors.

Of the companies cited, one should take voluntary action to correct its managing operations (50%). Additionally, one company had to take regulatory and/or administrative actions (50%).

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 Montgomery County Cities and the citations they received in Q4 2023
Company NameArea of BusinessInspection DateIssue Cited
BNG Miracle Pet, LLCVeterinary10/10/2023Hazard Analysis
BNG Miracle Pet, LLCVeterinary10/10/2023Preventive Controls
BNG Miracle Pet, LLCVeterinary10/10/2023Adequacy of Corrective Actions Implemented
BNG Miracle Pet, LLCVeterinary10/10/2023Validation of Process or Other Preventive Control
Johnson Medtech, LLCDevices11/27/2023Production processes
Johnson Medtech, LLCDevices11/27/2023Documentation
Johnson Medtech, LLCDevices11/27/2023Acceptance status
Johnson Medtech, LLCDevices11/27/2023Lack of or inadequate procedures

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