Hilary Marston, M.D., M.P.H. Chief Medical Officer (CMO) of the FDA | Official Website
Hilary Marston, M.D., M.P.H. Chief Medical Officer (CMO) of the FDA | Official Website
This is a 16.7% decrease from the number of companies cited in the previous quarter.
Of the 16 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 (80%). Additionally, one company had to take regulatory and/or administrative actions (20%).
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 |
|---|---|---|---|
| Juquilita Mexican Imports, LLC | Food and Cosmetics | 02/02/2024 | Develop FSVP |
| Northwest Eye Design, LLC | Devices | 02/02/2024 | Label to bear a unique device identifier |
| Northwest Eye Design, LLC | Devices | 02/02/2024 | Remedial action |
| Punjab Trading, Inc. | Food and Cosmetics | 03/07/2024 | Plant construction and design |
| Punjab Trading, Inc. | Food and Cosmetics | 03/07/2024 | Manufacturing, processing, packing, holding - Controls |
| Punjab Trading, Inc. | Food and Cosmetics | 03/07/2024 | Storage and Distribution |
| S & L Trade, Inc. | Food and Cosmetics | 03/19/2024 | Develop FSVP |
| S & L Trade, Inc. | Food and Cosmetics | 03/19/2024 | Hazard analysis written |
| S & L Trade, Inc. | Food and Cosmetics | 03/19/2024 | Hazard analysis biological, chemical, physical |
| S & L Trade, Inc. | Food and Cosmetics | 03/19/2024 | Evaluation - performance, risk |
| S & L Trade, Inc. | Food and Cosmetics | 03/19/2024 | Supplier approval - document |
| S & L Trade, Inc. | Food and Cosmetics | 03/19/2024 | Approved supplier procedures - importer established |
| S & L Trade, Inc. | Food and Cosmetics | 03/19/2024 | Verification activity assurance |
| S & L Trade, Inc. | Food and Cosmetics | 03/19/2024 | Verification activity before import, periodically |
| S & L Trade, Inc. | Food and Cosmetics | 03/19/2024 | Identification - entry |
| Siemens Medical Solutions USA, Inc. | Devices | 01/31/2024 | Lack of or inadequate complaint procedures |
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