Mark Raza Principal Deputy Chief Counsel - FDA | Official Website
Mark Raza Principal Deputy Chief Counsel - FDA | Official Website
This is a 38.5% decrease from the number of companies cited in the previous quarter.
Of the 18 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, four should take voluntary actions to correct their managing operations (50%). Additionally, three companies had to take regulatory and/or administrative actions (37.5%).
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 |
---|---|---|---|
Aracely Express, Inc. | Food and Cosmetics | 11/20/2023 | Written procedures - pest control |
Aracely Express, Inc. | Food and Cosmetics | 11/20/2023 | Reserve sample - collect, hold |
Aracely Express, Inc. | Food and Cosmetics | 11/20/2023 | Written procedures - holding |
Aracely Express, Inc. | Food and Cosmetics | 11/20/2023 | Records - returned dietary supplement: written procedures |
Aracely Express, Inc. | Food and Cosmetics | 11/20/2023 | Written procedures - product complaint; review, investigate |
Himalaya Wellness USA, Ltd. | Food and Cosmetics | 12/05/2023 | Written procedure quality control operations material review |
Himalaya Wellness USA, Ltd. | Food and Cosmetics | 12/05/2023 | QC operations - packaged, labeled; specifications |
Meditco, Inc. | Food and Cosmetics | 11/15/2023 | Develop FSVP |
Mega Harvest Corporation | Food and Cosmetics | 10/25/2023 | Develop FSVP |
Minland of Texas, Inc. | Food and Cosmetics | 10/06/2023 | Develop FSVP |
Regino Produce, LLC | Food and Cosmetics | 10/27/2023 | Develop FSVP |
Seatex, LLC | Drugs | 10/20/2023 | Procedures not in writing, fully followed |
Seatex, LLC | Drugs | 10/20/2023 | Written procedures not established/followed |
Seatex, LLC | Drugs | 10/20/2023 | Control procedures to monitor and validate performance |
Seatex, LLC | Drugs | 10/20/2023 | Expiration date lacking |
Seatex, LLC | Drugs | 10/20/2023 | Scientifically sound laboratory controls |
Seatex, LLC | Drugs | 10/20/2023 | Complete test data included in records |
Walker Coffee Trading, L. P. | Food and Cosmetics | 10/16/2023 | Hazard analysis written |