Mark Raza Principal Deputy Chief Counsel - FDA | Official Website
Mark Raza Principal Deputy Chief Counsel - FDA | Official Website
This is an increase over the number of companies cited in the previous quarter.
The citations in the county include:
- The organizational structure has not been adequately established and maintained to ensure that devices are produced in accordance with 21 CFR 820.
- Procedures to control labeling activities have not been adequately established.
- Labels were not printed so as to remain legible during processing, storage, handling, distribution, and/or use.
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.
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, according to its website.
| Company Name | Area of Business | Inspection Date | Issue Cited |
|---|---|---|---|
| Kervan USA, LLC | Food and Cosmetics | 09/11/2024 | Develop FSVP |
| Pittsburgh Spice & Seasoning Company, Inc. | Food and Cosmetics | 08/26/2024 | Hazard analysis - Identification of hazard |
| Pittsburgh Spice & Seasoning Company, Inc. | Food and Cosmetics | 08/26/2024 | Preventive controls records - General requirements |
| Pittsburgh Spice & Seasoning Company, Inc. | Food and Cosmetics | 08/26/2024 | Supply-chain program - Assurance (Adequate) |
| Pittsburgh Spice & Seasoning Company, Inc. | Food and Cosmetics | 08/26/2024 | Supply-chain program - Supplier approval |
| SEKO MedTec Solutions | Devices | 07/08/2024 | Lack of or inadequate organizational structure |
| SEKO MedTec Solutions | Devices | 07/08/2024 | Lack of or inadequate procedures for labeling |
| SEKO MedTec Solutions | Devices | 07/08/2024 | Remain legible |
| SEKO MedTec Solutions | Devices | 07/08/2024 | Examination for accuracy |
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