There were four companies in cities associated with Rockland County that received FDA citations as a result of four inspections conducted in the county throughout 2024, according to reports from the U.S. Food and Drug Administration (FDA).
This is a 33.3% increase over the number of companies cited in the previous year.
Of the 15 citations issued, the most common citation was ‘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’.
All of the companies cited were involved in the Drugs sector.
All of the 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 |
|---|---|---|---|
| Chartwell Life Sciences, LLC | Drugs | 04/08/2024 | Interval |
| Chartwell Life Sciences, LLC | Drugs | 04/08/2024 | Late submission of annual safety reports |
| Chartwell Life Sciences, LLC | Drugs | 04/08/2024 | Late submission of quarterly safety reports |
| Chartwell Life Sciences, LLC | Drugs | 04/08/2024 | Timely submission |
| Intercos America, Inc. | Drugs | 10/09/2024 | Computer control of master formula records |
| RK Pharma, Inc. | Drugs | 05/31/2024 | Equipment Design, Size and Location |
| RK Pharma, Inc. | Drugs | 05/31/2024 | Cleaning / Sanitizing / Maintenance |
| RK Pharma, Inc. | Drugs | 05/31/2024 | Computer control of master formula records |
| RK Pharma, Inc. | Drugs | 05/31/2024 | Scientifically sound laboratory controls |
| RK Pharma, Inc. | Drugs | 05/31/2024 | Records of disposition of rejected material |
| Vitane Pharmaceutical, Inc. | Drugs | 10/23/2024 | Cleaning / Sanitizing / Maintenance |
| Vitane Pharmaceutical, Inc. | Drugs | 10/23/2024 | Reports of Analysis (Components) |
| Vitane Pharmaceutical, Inc. | Drugs | 10/23/2024 | Absence of Written Procedures |
| Vitane Pharmaceutical, Inc. | Drugs | 10/23/2024 | Storage under appropriate conditions |
| Vitane Pharmaceutical, Inc. | Drugs | 10/23/2024 | Records reviewed annually |


