There were eight companies in cities associated with Delaware County that received FDA citations as a result of eight inspections conducted in the county in 2025, according to the U.S. Food and Drug Administration (FDA).
This is a 166.7% increase over the number of companies cited in the previous year.
The citations in the county include:
- You did not develop an FSVP.
- Protective apparel is not worn as necessary to protect drug products from contamination.
- Equipment and utensils are not cleaned, maintained and sanitized at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product.
Most of the companies cited were involved in the Food and Cosmetics 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 and quality.
| Company Name | Area of Business | Inspection Date | Issue Cited |
|---|---|---|---|
| Air Culinaire – Philadelphia | Food and Cosmetics | 05/06/2025 | Grounds |
| Air Culinaire – Philadelphia | Food and Cosmetics | 05/06/2025 | Sanitation of non-food-contact surfaces – Manner and frequency |
| Air Culinaire – Philadelphia | Food and Cosmetics | 05/06/2025 | Food safety plan – Preparation |
| Air Culinaire – Philadelphia | Food and Cosmetics | 05/06/2025 | Hazard analysis – Conducted |
| Carlino’s Specialty Food, Inc. | Food and Cosmetics | 05/02/2025 | Develop FSVP |
| GWR Medical, Inc. | Devices | 07/16/2025 | Management review – defined interval, sufficient frequency |
| GWR Medical, Inc. | Devices | 07/16/2025 | Quality Audit/Reaudit – conducted |
| GWR Medical, Inc. | Devices | 07/16/2025 | Design history file |
| GWR Medical, Inc. | Devices | 07/16/2025 | Evaluation of suppliers, contractors, etc., requirements |
| Gourmail, Inc. | Food and Cosmetics | 06/06/2025 | Processing: conform to other systems |
| Gourmail, Inc. | Food and Cosmetics | 06/06/2025 | Temperature-indicating device accuracy – initial temperature |
| PathoQuest, Inc. | Drugs | 10/31/2025 | Computer control of master formula records |
| Quotient Sciences – Philadelphia, LLC | Drugs | 09/17/2025 | Protective Apparel Not Worn |
| Quotient Sciences – Philadelphia, LLC | Drugs | 09/17/2025 | Cleaning / Sanitizing / Maintenance |
| Quotient Sciences – Philadelphia, LLC | Drugs | 09/17/2025 | Written procedures not established/followed |
| SR Rosati, Inc. | Food and Cosmetics | 08/22/2025 | Sanitation preventive controls – Appropriate (Adequate) |
| SR Rosati, Inc. | Food and Cosmetics | 08/22/2025 | Supply-chain program – Implement |
| Uramix, Inc. | Devices | 05/20/2025 | Lack of Written MDR Procedures |
| Uramix, Inc. | Devices | 05/20/2025 | Quality System Procedures |
