Vid Desai FDA’s Chief Information Officer | Official Website
Vid Desai FDA’s Chief Information Officer | Official Website
This is a 200% increase over the number of companies cited in the previous month.
Of the 11 citations issued, the most common citation was 'You did not develop an FSVP'.
Most of the companies cited were involved in the Food and Cosmetics sector.
Of the companies cited, one should take voluntary action to correct its managing operations (33.3%). Additionally, two companies had to take regulatory and/or administrative actions (66.7%).
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 |
|---|---|---|---|
| Dexcom, Inc. | Devices | 11/07/2024 | Design input - Lack of or inadequate procedures |
| Dexcom, Inc. | Devices | 11/07/2024 | Design output - Lack of or inadequate procedures |
| Dexcom, Inc. | Devices | 11/07/2024 | Design Validation - Risk analysis not performed/inadequate |
| Dexcom, Inc. | Devices | 11/07/2024 | Design changes - Lack of or Inadequate Procedures |
| Dexcom, Inc. | Devices | 11/07/2024 | Lack of or inadequate process validation |
| Dexcom, Inc. | Devices | 11/07/2024 | Lack/Inad procedure-Monitoring/Control of Validated Proces |
| Dexcom, Inc. | Devices | 11/07/2024 | Lack of or inadequate procedures |
| Gongora USA Corporation | Food and Cosmetics | 11/15/2024 | Develop FSVP |
| Trade Rooster, Inc. | Food and Cosmetics | 11/12/2024 | Develop FSVP |
| Trade Rooster, Inc. | Food and Cosmetics | 11/12/2024 | Supplier approval - document |
| Trade Rooster, Inc. | Food and Cosmetics | 11/12/2024 | Verification activity before import, periodically |
Alerts Sign-up