There were five companies in cities associated with Mercer County that received FDA citations as a result of five inspections conducted in the county throughout 2024, according to reports from the U.S. Food and Drug Administration (FDA).
This is a 400% increase over the number of companies cited in the previous year.
Of the 34 citations issued, the most common citations were ‘There is no written testing program designed to assess the stability characteristics of drug products’ and ‘You did not take a reasonable measure or precaution related to personnel practices’.
Most of the companies cited were involved in either Drugs or Food and Cosmetics sectors.
Of the companies cited, three should take voluntary actions to correct their managing operations (60%). Additionally, two companies had to take regulatory and/or administrative actions (40%).
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 |
|---|---|---|---|
| Acino Products, LLC | Drugs | 08/30/2024 | Contract drug products–lack of responsibility |
| Acino Products, LLC | Drugs | 08/30/2024 | Procedures not in writing, fully followed |
| Acino Products, LLC | Drugs | 08/30/2024 | Equipment for Environmental Control |
| Acino Products, LLC | Drugs | 08/30/2024 | Sanitation–buildings not clean, free of infestation |
| Acino Products, LLC | Drugs | 08/30/2024 | Cleaning SOPs/instructions |
| Acino Products, LLC | Drugs | 08/30/2024 | Identity Testing of Each Component |
| Acino Products, LLC | Drugs | 08/30/2024 | Absence of Written Procedures |
| Acino Products, LLC | Drugs | 08/30/2024 | Procedures for non-sterile drug products |
| Acino Products, LLC | Drugs | 08/30/2024 | Lack of written stability program |
| Acino Products, LLC | Drugs | 08/30/2024 | Items to cover on annual reviews |
| Epicare Acquisitions, LLC | Devices | 12/13/2024 | Label to bear a unique device identifier |
| Epicare Acquisitions, LLC | Devices | 12/13/2024 | Training – Lack of or inadequate procedures |
| Epicare Acquisitions, LLC | Devices | 12/13/2024 | Design validation- Lack of or inadequate procedures |
| Epicare Acquisitions, LLC | Devices | 12/13/2024 | Procedures not adequately established or maintained |
| Epicare Acquisitions, LLC | Devices | 12/13/2024 | Lack of or inadequate procedures |
| Epicare Acquisitions, LLC | Devices | 12/13/2024 | DMR – not or inadequately maintained |
| Epicare Acquisitions, LLC | Devices | 12/13/2024 | DHR content |
| Epicare Acquisitions, LLC | Devices | 12/13/2024 | Lack of or inadequate complaint procedures |
| Epicare Acquisitions, LLC | Devices | 12/13/2024 | Devices subject to device identification GUDID data submission requirements. |
| Epicare Acquisitions, LLC | Devices | 12/13/2024 | Manufacture date abbreviated or unapproved date coding |
| Peoples Bakery, Inc. | Food and Cosmetics | 03/19/2024 | Personnel |
| Peoples Bakery, Inc. | Food and Cosmetics | 03/19/2024 | Sanitary operations – Plant maintenance |
| Peoples Bakery, Inc. | Food and Cosmetics | 03/19/2024 | Manufacturing, processing, packing, holding – Controls |
| Route 33 Cafe, Inc. | Food and Cosmetics | 01/30/2024 | Personnel |
| Route 33 Cafe, Inc. | Food and Cosmetics | 01/30/2024 | Equipment and utensils – Design and maintenance |
| Route 33 Cafe, Inc. | Food and Cosmetics | 01/30/2024 | Food safety plan |
| Salvona Technologies, LLC | Drugs | 10/18/2024 | Procedures not in writing, fully followed |
| Salvona Technologies, LLC | Drugs | 10/18/2024 | Written procedures not established/followed |
| Salvona Technologies, LLC | Drugs | 10/18/2024 | Calibration/Inspection/Checking not done |
| Salvona Technologies, LLC | Drugs | 10/18/2024 | Absence of Written Procedures |
| Salvona Technologies, LLC | Drugs | 10/18/2024 | Strict control not exercised over labeling issued |
| Salvona Technologies, LLC | Drugs | 10/18/2024 | Storage under appropriate conditions |
| Salvona Technologies, LLC | Drugs | 10/18/2024 | Instruments, apparatus, et. al. not meeting specs |
| Salvona Technologies, LLC | Drugs | 10/18/2024 | Lack of written stability program |
