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.
| 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) |


