There were five companies in cities associated with Orange County that received FDA citations as a result of five inspections conducted in the county over the first quarter of 2025, according to reports from the U.S. Food and Drug Administration (FDA).
This is a 44.4% decrease from the number of companies cited in the previous quarter.
Of the 15 citations issued, the most common citation was ‘Records were not retained for the appropriate length of time, 10 years after their creation’.
Most of the companies cited were involved in the Biologics 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 quality.
| Company Name | Area of Business | Inspection Date | Issue Cited |
|---|---|---|---|
| Fangyinmeng Inc., M.D. | Biologics | 02/18/2025 | Testing, screening, donor eligibility procedures |
| Fangyinmeng Inc., M.D. | Biologics | 02/18/2025 | Documentation–determination, by whom, date |
| McKenna Labs, Inc. | Drugs | 02/13/2025 | Prepared for each batch, include complete information |
| McKenna Labs, Inc. | Drugs | 02/13/2025 | Calculations performed are in the records |
| Nellson Nutraceuticals, LLC | Food and Cosmetics | 01/07/2025 | Hazard analysis – Identification of hazard |
| Nellson Nutraceuticals, LLC | Food and Cosmetics | 01/07/2025 | Sanitation preventive controls – Identify (Written) |
| Nellson Nutraceuticals, LLC | Food and Cosmetics | 01/07/2025 | Supply-chain program – Assurance (Adequate) |
| Sports Tek Medical, Inc. | Biologics | 01/23/2025 | Storage temperatures recorded, maintained |
| Sports Tek Medical, Inc. | Biologics | 01/23/2025 | Evaluation–microorganisms, damage |
| Sports Tek Medical, Inc. | Biologics | 01/23/2025 | Retention time (10 year rules) |
| Tox Laboratory, M.D. | Biologics | 01/28/2025 | All core requirements covered in program |
| Tox Laboratory, M.D. | Biologics | 01/28/2025 | Procedures to meet core CTGP |
| Tox Laboratory, M.D. | Biologics | 01/28/2025 | Records incomplete |
| Tox Laboratory, M.D. | Biologics | 01/28/2025 | Management system re: core CGTPs |
| Tox Laboratory, M.D. | Biologics | 01/28/2025 | Retention time (10 year rules) |
