Vid Desai FDA’s Chief Information Officer | Official Website
Vid Desai FDA’s Chief Information Officer | Official Website
This is a 60% decrease from the number of companies cited in the previous quarter.
Of the 17 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.
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 |
---|---|---|---|
Applevalley Organics, Corporation, Inc. | Veterinary | 11/07/2024 | Develop FSVP |
Ekos America, Inc. | Food and Cosmetics | 11/19/2024 | Hazard analysis written |
Ekos America, Inc. | Food and Cosmetics | 11/19/2024 | Evaluation, reevaluation - another entity |
Ekos America, Inc. | Food and Cosmetics | 11/19/2024 | Approved supplier procedures- another entity |
Ekos America, Inc. | Food and Cosmetics | 11/19/2024 | Record - translate to English |
Herba Natural Products, Inc. | Food and Cosmetics | 10/23/2024 | Animals and pests in facility |
Herba Natural Products, Inc. | Food and Cosmetics | 10/23/2024 | Specifications - finished dietary supplement |
Herba Natural Products, Inc. | Food and Cosmetics | 10/23/2024 | Specifications met - verify; finished batch |
Herba Natural Products, Inc. | Food and Cosmetics | 10/23/2024 | Corrective action plan |
Herba Natural Products, Inc. | Food and Cosmetics | 10/23/2024 | Written procedures - establish; quality control operations |
Herba Natural Products, Inc. | Food and Cosmetics | 10/23/2024 | Records - packaging, labeling operations |
Repro Lab | Biologics | 11/19/2024 | Abbreviated procedure |
Repro Lab | Biologics | 11/19/2024 | SOP for release; reactive for CMV |
Spice N' More Corporation | Food and Cosmetics | 11/27/2024 | Hazard analysis - Identification of hazard |
Spice N' More Corporation | Food and Cosmetics | 11/27/2024 | Process preventive controls - Identify (Written) |
Spice N' More Corporation | Food and Cosmetics | 11/27/2024 | Supply-chain program - Establish |
Threeline Imports, Inc. | Food and Cosmetics | 11/19/2024 | Develop FSVP |