Mark Raza Principal Deputy Chief Counsel - FDA | Official Website
Mark Raza Principal Deputy Chief Counsel - FDA | Official Website
This is a 116.7% increase over the number of companies cited in the previous year.
Of the 33 citations issued, the most common citation was 'Your written sanitation preventive control, monitoring and verification procedures were not appropriate to significantly minimize or prevent the hazard requiring a preventive control'.
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 Biologics sector.
Of the companies cited, 12 should take voluntary actions to correct their managing operations (92.3%).
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 |
|---|---|---|---|
| ALOM Technologies Corporation | Devices | 10/17/2024 | Lack of or inadequate procedures |
| Blair M. Brengle, M.D. | Drugs | 08/29/2024 | Case history records- inadequate or inadequate |
| Blair M. Brengle, M.D. | Drugs | 08/29/2024 | Safety Reports - Non-Serious Events |
| Chef for Hire, Inc. | Food and Cosmetics | 05/03/2024 | Hazard analysis |
| Chef for Hire, Inc. | Food and Cosmetics | 05/03/2024 | HACCP plan implementation |
| Chef for Hire, Inc. | Food and Cosmetics | 05/03/2024 | Food safety hazards |
| Chef for Hire, Inc. | Food and Cosmetics | 05/03/2024 | Verification procedures - none/frequency |
| Chef for Hire, Inc. | Food and Cosmetics | 05/03/2024 | Signed and dated |
| Chef for Hire, Inc. | Food and Cosmetics | 05/03/2024 | Sanitation monitoring |
| Chef for Hire, Inc. | Food and Cosmetics | 05/03/2024 | Sanitation Records |
| Community Fertility Specialty Care | Biologics | 01/11/2024 | Design of procedures to ensure compliance |
| Community Fertility Specialty Care | Biologics | 01/11/2024 | Documentation--determination, by whom, date |
| Community Fertility Specialty Care | Biologics | 01/11/2024 | Infection with communicable disease agents |
| Concentrics Research, LLC | Drugs | 11/26/2024 | Record retention requirement |
| Cosmo's Superior Foods | Veterinary | 08/19/2024 | Personnel |
| Cosmo's Superior Foods | Veterinary | 08/19/2024 | Hazard Analysis |
| Cosmo's Superior Foods | Veterinary | 08/19/2024 | Validation of Process or Other Preventive Control |
| Hong Sar, LLC | Food and Cosmetics | 09/13/2024 | Pest control |
| Krispy Kreme Doughnut Corporation | Food and Cosmetics | 03/07/2024 | Sanitation preventive controls - Implement |
| Krispy Kreme Doughnut Corporation | Food and Cosmetics | 03/07/2024 | Sanitation preventive controls - Appropriate (Adequate) |
| Mondelez Global, LLC | Food and Cosmetics | 01/11/2024 | Sanitation preventive controls - Appropriate (Adequate) |
| Ossium Health, Inc. | Biologics | 05/30/2024 | Specified requirements for in-process controls |
| Ossium Health, Inc. | Biologics | 05/30/2024 | Records maintained concurrently |
| Pasta-Bilities, Inc. | Food and Cosmetics | 06/24/2024 | Process control - Foreign objects |
| Versiti Indiana, Inc. | Biologics | 09/30/2024 | Establish, maintain and follow manufacturing SOPs |
| Versiti Indiana, Inc. | Biologics | 09/30/2024 | Concurrent documentation |
| Versiti Indiana, Inc. | Biologics | 09/30/2024 | Person performing, test results, interpretation |
| Versiti Indiana, Inc. | Biologics | 09/30/2024 | Cleaned, sanitized per established schedules |
| Versiti Indiana, Inc. | Biologics | 09/30/2024 | Procedures and release criteria |
| Versiti Indiana, Inc. | Biologics | 09/30/2024 | Records incomplete |
| Vesta Pharmaceuticals, Inc. | Food and Cosmetics | 02/09/2024 | Quality control operations - calibration records |
| Vesta Pharmaceuticals, Inc. | Food and Cosmetics | 02/09/2024 | Batch record - quality control review; production |
| Vesta Pharmaceuticals, Inc. | Food and Cosmetics | 02/09/2024 | Hold - mix-up, contamination, deterioration |
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