Vid Desai FDA’s Chief Information Officer | Official Website
Vid Desai FDA’s Chief Information Officer | Official Website
This is unchanged from the number of companies cited in the previous month.
The citations in the county include:
- You did not develop an FSVP.
- You did not have a written hazard analysis.
- You did not document that you approved a foreign supplier based on an evaluation that you conducted of the foreign supplier's performance and the risk posed by a food or based on a review and assessment of another entity's evaluation of a foreign supplier's performance and the risk posed by a food.
Both companies cited were involved in either Food and Cosmetics or Drugs sectors.
Both 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 |
---|---|---|---|
Bonafide Innovations, LLC | Drugs | 05/06/2024 | GMP Training Frequency |
Bonafide Innovations, LLC | Drugs | 05/06/2024 | Buildings of Suitable Size, Construction, Location |
Bonafide Innovations, LLC | Drugs | 05/06/2024 | Written procedures not established/followed |
FMT Services, LLC | Food and Cosmetics | 05/02/2024 | Develop FSVP |
FMT Services, LLC | Food and Cosmetics | 05/02/2024 | Hazard analysis written |
FMT Services, LLC | Food and Cosmetics | 05/02/2024 | Supplier approval - document |
FMT Services, LLC | Food and Cosmetics | 05/02/2024 | Reevaluate - 3 years |
FMT Services, LLC | Food and Cosmetics | 05/02/2024 | Approved supplier procedures - importer established |
FMT Services, LLC | Food and Cosmetics | 05/02/2024 | Supplier verification - establish written procedures |
FMT Services, LLC | Food and Cosmetics | 05/02/2024 | Verification activity assurance |
FMT Services, LLC | Food and Cosmetics | 05/02/2024 | Verification activity before import, periodically |