There were five companies in cities associated with Suffolk County that received FDA citations as a result of five inspections conducted in the county over the first quarter of 2025, according to reports from the U.S. Food and Drug Administration (FDA).
This is a 66.7% increase over the number of companies cited in the previous quarter.
The citations in the county include:
- The responsibilities and procedures applicable to the quality control unit are not fully followed.
- Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design and of adequate size to facilitate operations for its intended use.
- Your hazard analysis did not identify a hazard that required a preventive control.
Most 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 |
|---|---|---|---|
| Advance Pharmaceutical, Inc. | Drugs | 02/27/2025 | In-Process Material Area |
| Advance Pharmaceutical, Inc. | Drugs | 02/27/2025 | Handling and Storage to Prevent Contamination |
| Advance Pharmaceutical, Inc. | Drugs | 02/27/2025 | Following/documenting laboratory controls |
| Harvest Bakery, Inc. | Food and Cosmetics | 03/14/2025 | Personnel |
| Lillys Wholesale, Ltd. | Food and Cosmetics | 01/06/2025 | Hazard analysis – Identification of hazard |
| Positive Promotions | Drugs | 02/07/2025 | Procedures not in writing, fully followed |
| Positive Promotions | Drugs | 02/07/2025 | GMP Training Frequency |
| Positive Promotions | Drugs | 02/07/2025 | Reports of Analysis (Components) |
| Positive Promotions | Drugs | 02/07/2025 | Absence of Written Procedures |
| Positive Promotions | Drugs | 02/07/2025 | Identification of Equipment and Lines |
| Topiderm, Inc. | Drugs | 03/07/2025 | Procedures not in writing, fully followed |
| Topiderm, Inc. | Drugs | 03/07/2025 | Equipment Design, Size and Location |
