There were 10 companies in cities associated with Fulton County that received FDA citations as a result of 10 inspections conducted in the county throughout 2024, according to reports from the U.S. Food and Drug Administration (FDA).
This is unchanged from the number of companies cited in the previous year.
Of the 32 citations issued, the most common citation was ‘Your hazard analysis did not identify a hazard that required a preventive control’.
Most of the companies cited were involved in the Food and Cosmetics sector.
Of the companies cited, eight should take voluntary actions to correct their managing operations (80%). Additionally, two companies had to take regulatory and/or administrative actions (20%).
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 |
|---|---|---|---|
| Acella Pharmaceuticals, LLC | Drugs | 12/18/2024 | Late submission of annual safety reports |
| Acella Pharmaceuticals, LLC | Drugs | 12/18/2024 | Late submission of quarterly safety reports |
| Acella Pharmaceuticals, LLC | Drugs | 12/18/2024 | Timely submission |
| Auto-Chlor System, LLC | Drugs | 06/18/2024 | Procedures not in writing, fully followed |
| Auto-Chlor System, LLC | Drugs | 06/18/2024 | Training–operations, GMPs, written procedures |
| Auto-Chlor System, LLC | Drugs | 06/18/2024 | Reports of Analysis (Components) |
| Auto-Chlor System, LLC | Drugs | 06/18/2024 | Control procedures to monitor and validate performance |
| Auto-Chlor System, LLC | Drugs | 06/18/2024 | Scientifically sound laboratory controls |
| Auto-Chlor System, LLC | Drugs | 06/18/2024 | Testing and release for distribution |
| Auto-Chlor System, LLC | Drugs | 06/18/2024 | Written program not followed |
| Auto-Chlor System, LLC | Drugs | 06/18/2024 | Active ingredient retained sample kept |
| Auto-Chlor System, LLC | Drugs | 06/18/2024 | Items to cover on annual reviews |
| Auto-Chlor System, LLC | Drugs | 06/18/2024 | Complete instructions, procedures, specifications et. al. |
| Auto-Chlor System, LLC | Drugs | 06/18/2024 | Distribution Record Requirements |
| Auto-Chlor System, LLC | Drugs | 06/18/2024 | Procedures to be written and followed |
| Coca-Cola North America – Atlanta Syrup Branch | Food and Cosmetics | 12/19/2024 | Hazard analysis – Identification of hazard |
| Gate Gourmet #301 | Food and Cosmetics | 02/28/2024 | Sanitary facilities and controls |
| Gate Gourmet #301 | Food and Cosmetics | 02/28/2024 | Allergen preventive controls – Implement |
| Gate Gourmet #301 | Food and Cosmetics | 02/28/2024 | Process preventive controls – Appropriate (Adequate) |
| Gate Gourmet #301 | Food and Cosmetics | 02/28/2024 | Supply-chain program – Assurance (Adequate) |
| Hartybake, LLC | Food and Cosmetics | 02/02/2024 | Hazard analysis – Identification of hazard |
| Hinsdale & Foster Provisions, LLC | Food and Cosmetics | 05/09/2024 | Allergen preventive controls – Implement |
| Hinsdale & Foster Provisions, LLC | Food and Cosmetics | 05/09/2024 | Process preventive controls – Appropriate (Adequate) |
| Hinsdale & Foster Provisions, LLC | Food and Cosmetics | 05/09/2024 | Sanitation preventive controls – Appropriate (Adequate) |
| J. Robert Flamini | Drugs | 03/11/2024 | FD-1572, protocol compliance |
| Processors Company Op, Inc. | Food and Cosmetics | 09/27/2024 | Develop FSVP |
| Trulli2, LLC | Food and Cosmetics | 04/19/2024 | Sanitary operations – Plant sanitation |
| Trulli2, LLC | Food and Cosmetics | 04/19/2024 | Process control – Foreign objects |
| Well Luck Company, Inc. | Food and Cosmetics | 08/21/2024 | Qualifications of individuals |
| Well Luck Company, Inc. | Food and Cosmetics | 08/21/2024 | Sanitary operations – Plant maintenance |
| Well Luck Company, Inc. | Food and Cosmetics | 08/21/2024 | Food safety plan |
| Well Luck Company, Inc. | Food and Cosmetics | 08/21/2024 | Customer disclosure |

