There was one company in a city associated with Essex County that received FDA citations as a result of one inspection conducted in the county in July, according to reports from the U.S. Food and Drug Administration (FDA).
This is an increase over the number of companies cited in the previous month.
The citations in the county include:
- The responsibilities and procedures applicable to the quality control unit are not in writing.
- GMP training is not conducted on a continuing basis and with sufficient frequency to assure that employees remain familiar with CGMP requirements applicable to them.
- Appropriate controls are not exercised over computers or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel.
The company cited should take a voluntary action to correct its 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.
| Company Name | Area of Business | Inspection Date | Issue Cited |
|---|---|---|---|
| Welch, Holme & Clark Company, Inc. | Drugs | 07/10/2024 | Procedures not in writing, fully followed |
| Welch, Holme & Clark Company, Inc. | Drugs | 07/10/2024 | GMP Training Frequency |
| Welch, Holme & Clark Company, Inc. | Drugs | 07/10/2024 | Computer control of master formula records |
