There were two companies in a city associated with Fairfield County that received FDA citations as a result of two inspections conducted in the county over the second quarter of 2025, according to reports from the U.S. Food and Drug Administration (FDA).
This is an increase over the number of companies cited in the previous quarter.
The citations in the county include:
- You did not develop an FSVP.
- Procedures for management review have not been adequately established.
- Procedures for quality audits have not been adequately established.
The companies cited were involved in either Food and Cosmetics or Devices sectors.
Both 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 |
|---|---|---|---|
| Aunt Flow, CORP | Devices | 05/08/2025 | Management review – Lack of or inadequate procedures |
| Aunt Flow, CORP | Devices | 05/08/2025 | Quality audits – Lack of or inadequate procedures |
| Aunt Flow, CORP | Devices | 05/08/2025 | Training – Lack of or inadequate procedures |
| Aunt Flow, CORP | Devices | 05/08/2025 | Design control – no procedures |
| Aunt Flow, CORP | Devices | 05/08/2025 | Evaluation of suppliers, contractors, etc., requirements |
| Aunt Flow, CORP | Devices | 05/08/2025 | Lack of or inadequate procedures |
| Aunt Flow, CORP | Devices | 05/08/2025 | Lack of or inadequate complaint procedures |
| Jain Americas, Inc. | Food and Cosmetics | 04/14/2025 | Develop FSVP |
