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Saturday, November 23, 2024

FDA issued 19 citations in cities across San Bernardino County 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 seven companies in cities associated with San Bernardino County that received FDA citations as a result of seven 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 a 16.7% increase over the number of companies cited in the previous quarter.

The citations in the county include:

  • You did not provide FDA with information on the scheduled process for a new acidified food before packing the food.
  • Each container is not marked with an identifying code specifying the establishment where the product was packed.
  • The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.

Most of the companies cited were involved in the Food and Cosmetics sector.

Of the companies cited, six should take voluntary actions to correct their managing operations (85.7%). Additionally, one company had to take regulatory and/or administrative actions (14.3%).

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 San Bernardino County Cities and the citations they received in Q4 2023
Company NameArea of BusinessInspection DateIssue Cited
DPI Specialty Foods West, Inc.Food and Cosmetics10/17/2023Develop FSVP
Maple Lane Bakery, Inc.Food and Cosmetics10/27/2023Personnel
Maple Lane Bakery, Inc.Food and Cosmetics10/27/2023Plant construction and design
Myojo USA, Inc.Food and Cosmetics11/01/2023Process filing
Myojo USA, Inc.Food and Cosmetics11/01/2023Code - required elements
San Bernardino International AirportFood and Cosmetics10/25/2023Prevention of the spread of communicable diseases
San Bernardino International AirportFood and Cosmetics10/25/2023Prevention of contamination
Sky Chefs, Inc.Food and Cosmetics10/27/2023Manufacturing, processing, packing, holding - Controls
Table de France, Inc.Food and Cosmetics10/20/2023Sanitation of non-food-contact surfaces - Manner and frequency
Table de France, Inc.Food and Cosmetics10/20/2023Manufacturing, processing, packing, holding - Controls
Table de France, Inc.Food and Cosmetics10/20/2023Process control - Foreign objects
Universal Packaging Systems, Inc.Drugs11/17/2023Procedures not in writing, fully followed
Universal Packaging Systems, Inc.Drugs11/17/2023Mfg / Processing Operations Area
Universal Packaging Systems, Inc.Drugs11/17/2023Written procedures not established/followed
Universal Packaging Systems, Inc.Drugs11/17/2023Computer control of master formula records
Universal Packaging Systems, Inc.Drugs11/17/2023Absence of Written Procedures
Universal Packaging Systems, Inc.Drugs11/17/2023Following/documenting laboratory controls
Universal Packaging Systems, Inc.Drugs11/17/2023Scientifically sound laboratory controls
Universal Packaging Systems, Inc.Drugs11/17/2023Extent of discrepancy, failure investigations

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