Dr. Namandjé N. Bumpus Principal Deputy Commissioner - FDA | Official Website
Dr. Namandjé N. Bumpus Principal Deputy Commissioner - FDA | Official Website
This is an increase over the number of companies cited in the previous month.
The citations in the county include:
- You did not make and keep documentation of training.
- You did not follow written procedures for quality control operations for conducting a material review and making a disposition decision.
- Your quality control operations did not include determining whether each finished batch conforms to established product specifications.
The company cited should take a voluntary action to correct its 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 |
|---|---|---|---|
| Stim-O-Stam, Ltd. | Food and Cosmetics | 05/08/2024 | Personnel - records - training |
| Stim-O-Stam, Ltd. | Food and Cosmetics | 05/08/2024 | Written procedure quality control operations material review |
| Stim-O-Stam, Ltd. | Food and Cosmetics | 05/08/2024 | Quality control operations - finished batch, specifications |
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