Namandjé N. Bumpus Principal Deputy Commissioner at U.S. Food And Drug Administration (fda) | Official website
Namandjé N. Bumpus Principal Deputy Commissioner at U.S. Food And Drug Administration (fda) | Official website
This is a 200% increase over the number of companies cited in the previous year.
The citations in the county include:
- Your hazard analysis did not identify a hazard that requires a control.
- The organizational structure has not been established and maintained to ensure that devices are designed and produced in accordance with 21 CFR 820.
- Design validation did not ensure the device conforms to defined user needs and intended uses.
Of the companies cited, two should take voluntary actions to correct their managing operations (66.7%). Additionally, one company had to take regulatory and/or administrative actions (33.3%).
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.
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 |
---|---|---|---|
Sea Watch International, Ltd. | Food and Cosmetics | 08/02/2023 | HACCP plan implementation |
Tesla Biohealing, Inc. | Devices | 03/23/2023 | Lack of or inadequate organizational structure |
Tesla Biohealing, Inc. | Devices | 03/23/2023 | Design validation - user needs and intended uses |
Tesla Biohealing, Inc. | Devices | 03/23/2023 | Evaluation and Selection, Suppliers, Contractors, etc. |
Tesla Biohealing, Inc. | Devices | 03/23/2023 | Equipment suitability & capability |
VLM Foods USA, Ltd. | Food and Cosmetics | 06/08/2023 | Hazard analysis biological, chemical, physical |
ORGANIZATIONS IN THIS STORY
!RECEIVE ALERTS