Namandjé N. Bumpus Principal Deputy Commissioner at U.S. Food And Drug Administration (fda) | Official website
Namandjé N. Bumpus Principal Deputy Commissioner at U.S. Food And Drug Administration (fda) | Official website
This is a 50% decrease from the number of companies cited in the previous quarter.
Of the 21 citations issued, the most common citation was 'You did not conduct and document or obtain documentation of one or more supplier verification activities'.
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 |
|---|---|---|---|
| Allermed Laboratories, LLC | Biologics | 01/31/2024 | Lack of quality control unit |
| Allermed Laboratories, LLC | Biologics | 01/31/2024 | Procedures not in writing, fully followed |
| Allermed Laboratories, LLC | Biologics | 01/31/2024 | Clothing appropriate for duties performed |
| Allermed Laboratories, LLC | Biologics | 01/31/2024 | Buildings of Suitable Size, Construction, Location |
| Allermed Laboratories, LLC | Biologics | 01/31/2024 | Environmental Monitoring System |
| Allermed Laboratories, LLC | Biologics | 01/31/2024 | Buildings not maintained in good state of repair |
| Allermed Laboratories, LLC | Biologics | 01/31/2024 | Equipment Design, Size and Location |
| Allermed Laboratories, LLC | Biologics | 01/31/2024 | Procedures for sterile drug products |
| Allermed Laboratories, LLC | Biologics | 01/31/2024 | Records reviewed annually |
| Allermed Laboratories, LLC | Biologics | 01/31/2024 | When to report |
| Allermed Laboratories, LLC | Biologics | 01/31/2024 | Reporting Requirements - 15-day alert |
| S&S Quality Wholesale, Inc. | Food and Cosmetics | 02/02/2024 | Develop FSVP |
| S&S Quality Wholesale, Inc. | Food and Cosmetics | 02/02/2024 | Verification activity before import, periodically |
| Sacks Holdings, Inc. | Devices | 03/29/2024 | Acceptable supplier records, inadequate records |
| Sacks Holdings, Inc. | Devices | 03/29/2024 | Lack of or inadequate final acceptance procedures |
| Sacks Holdings, Inc. | Devices | 03/29/2024 | DHR - not or inadequately maintained |
| Sun Grown Organic Distributors, Inc. | Food and Cosmetics | 02/29/2024 | Food contact surface sanitary inspection and maintenance |
| Sun Grown Organic Distributors, Inc. | Food and Cosmetics | 02/29/2024 | Prevent hazards on seed |
| Trade Rooster, Inc. | Food and Cosmetics | 03/25/2024 | LACF compliance |
| Trade Rooster, Inc. | Food and Cosmetics | 03/25/2024 | Supplier approval - document |
| Trade Rooster, Inc. | Food and Cosmetics | 03/25/2024 | Verification activity before import, periodically |
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