There were 12 companies in cities associated with Franklin County that received FDA citations as a result of 12 inspections conducted in the county throughout 2023, according to reports from the U.S. Food and Drug Administration (FDA).
This is a 33.3% decrease from the number of companies cited in the previous year.
Of the 42 citations issued, the most common citations include:
- Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have not been adequately established.
- Your plant was not constructed and designed to facilitate maintenance and sanitary operations.
- 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.
Most of the companies cited were involved in the Food and Cosmetics sector. The second most common type of company cited in the time period worked in the the Devices 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.
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 |
|---|---|---|---|
| AVT Technologies, LLC. | Devices | 04/20/2023 | Lack of or inadequate complaint procedures |
| AVT Technologies, LLC. | Devices | 04/20/2023 | Servicing – Lack of or inadequate procedures |
| Big Lots, Inc. | Food and Cosmetics | 03/22/2023 | LACF compliance |
| Big Lots, Inc. | Food and Cosmetics | 03/22/2023 | Hazard analysis written |
| Big Lots, Inc. | Food and Cosmetics | 03/22/2023 | Supplier verification – establish written procedures |
| Big Lots, Inc. | Food and Cosmetics | 03/22/2023 | Verification activity frequency |
| Dan the Baker, LLC | Food and Cosmetics | 03/01/2023 | Personnel |
| Dan the Baker, LLC | Food and Cosmetics | 03/01/2023 | Plant construction and design |
| Dan the Baker, LLC | Food and Cosmetics | 03/01/2023 | Sanitary facilities and controls |
| GFS Chemicals, Inc. | Devices | 11/17/2023 | Lack/Inad procedure-Monitoring/Control of Validated Proces |
| IncludeHealth | Devices | 11/01/2023 | Management review – Lack of or inadequate procedures |
| IncludeHealth | Devices | 11/01/2023 | Quality audits – Lack of or inadequate procedures |
| IncludeHealth | Devices | 11/01/2023 | Design validation – software validation not performed |
| IncludeHealth | Devices | 11/01/2023 | Lack of or inadequate procedures |
| IncludeHealth | Devices | 11/01/2023 | Lack of or inadequate complaint procedures |
| James & James | Food and Cosmetics | 03/27/2023 | Develop FSVP |
| Mars Petcare US, Inc. | Food and Cosmetics | 01/23/2023 | Frequency: visual closure examinations, record |
| Mars Petcare US, Inc. | Veterinary | 01/23/2023 | Frequency: visual closure examinations, record |
| ODW Logistics, Inc. | Food and Cosmetics | 02/16/2023 | Plant construction and design |
| ODW Logistics, Inc. | Food and Cosmetics | 02/16/2023 | Pest control |
| Safecor Health, LLC | Drugs | 09/01/2023 | Identity Testing of Each Component |
| Safecor Health, LLC | Drugs | 09/01/2023 | Absence of Written Procedures |
| Safecor Health, LLC | Drugs | 09/01/2023 | Changes to Procedures Not Reviewed, Approved |
| Safecor Health, LLC | Drugs | 09/01/2023 | Reprocessing/quality control unit |
| Safecor Health, LLC | Drugs | 09/01/2023 | Sample size – test intervals |
| Safecor Health, LLC | Drugs | 09/01/2023 | Written records kept in individual logs |
| Safecor Health, LLC | Drugs | 09/01/2023 | Investigations of discrepancies, failures |
| Shasta Beverages, Inc. | Food and Cosmetics | 07/13/2023 | Sanitary operations – Plant maintenance |
| Shasta Beverages, Inc. | Food and Cosmetics | 07/13/2023 | Sanitation of non-food-contact surfaces – Manner and frequency |
| Tri Technician Laboratories, LLC | Drugs | 12/19/2023 | Procedures not in writing, fully followed |
| Tri Technician Laboratories, LLC | Drugs | 12/19/2023 | Computer control of master formula records |
| Tri Technician Laboratories, LLC | Drugs | 12/19/2023 | Identity Testing of Each Component |
| Tri Technician Laboratories, LLC | Drugs | 12/19/2023 | Reports of Analysis (Components) |
| Tri Technician Laboratories, LLC | Drugs | 12/19/2023 | Establishment of time limitations |
| Tri Technician Laboratories, LLC | Drugs | 12/19/2023 | Scientifically sound laboratory controls |
| Tri Technician Laboratories, LLC | Drugs | 12/19/2023 | Test methods |
| Tri Technician Laboratories, LLC | Drugs | 12/19/2023 | Valid stability test methods |
| Tri Technician Laboratories, LLC | Drugs | 12/19/2023 | Investigations of discrepancies, failures |
| Vesco Medical, LLC | Devices | 10/31/2023 | Design control – no procedures |
| Vesco Medical, LLC | Devices | 10/31/2023 | Purchasing controls, Lack of or inadequate procedures |
| Vesco Medical, LLC | Devices | 10/31/2023 | Lack of or inadequate procedures |
| Vesco Medical, LLC | Devices | 10/31/2023 | Investigation of device failures |
