How many companies in cities across Monmouth County received FDA citations in 2024?

How many companies in cities across Monmouth County received FDA citations in 2024?
James “Jim” Sigg FDA's Deputy Commissioner for Operations and Chief Operating Officer — Official Website
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There were two companies in cities associated with Monmouth County that received FDA citations as a result of two inspections conducted in the county throughout 2024, according to reports from the U.S. Food and Drug Administration (FDA).

This is a 100% increase over the number of companies cited in the previous year.

The citations in the county include:

  • There is no quality control unit.
  • Written procedures are not established for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product.
  • The identity of each component of a drug product is not verified by conducting at least one test to verify the identity, using specific identity tests if they exist.

The companies cited were involved in either Drugs or Food and Cosmetics sectors.

Both 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.

According to its website, 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.

Companies Located Within Monmouth County Cities and the Citations They Received in 2024
Company Name Area of Business Inspection Date Issue Cited
Alkaline Corporation Drugs 09/06/2024 Lack of quality control unit
Alkaline Corporation Drugs 09/06/2024 Written procedures not established/followed
Alkaline Corporation Drugs 09/06/2024 Identity Testing of Each Component
Alkaline Corporation Drugs 09/06/2024 Establish reliability of supplier’s C of A
Alkaline Corporation Drugs 09/06/2024 Sampling/testing of labeling/packaging materials
Alkaline Corporation Drugs 09/06/2024 Lack of written stability program
Alkaline Corporation Drugs 09/06/2024 Prepared for each batch, include complete information
Jersey Shore CML, LLC Food and Cosmetics 11/12/2024 Hazard analysis – Identification of hazard
Jersey Shore CML, LLC Food and Cosmetics 11/12/2024 Allergen preventive controls – Appropriate (Adequate)
Jersey Shore CML, LLC Food and Cosmetics 11/12/2024 Sanitation preventive controls – Appropriate (Adequate)


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