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 42.9% increase over the number of companies cited in the previous year.
Of the 49 citations issued, the most common citation was 'The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed'.
Most of the companies cited were involved in the Food and Cosmetics sector. The second most common type of company cited in the time period worked in the Drugs sector.
Of the companies cited, eight should take voluntary actions to correct their managing operations (80%). Additionally, two companies 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.
According to its website, 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.
| Company Name | Area of Business | Inspection Date | Issue Cited |
|---|---|---|---|
| BB Global Supplies Chain, LLC. | Food and Cosmetics | 04/05/2024 | Develop FSVP |
| Blue Line Food Service Distribution | Food and Cosmetics | 12/06/2024 | Allergen preventive controls - Appropriate (Adequate) |
| Capital Sales Company Ferndale, Mi | Food and Cosmetics | 02/14/2024 | Develop FSVP |
| Excel Medical Products, Inc. | Devices | 04/01/2024 | Statistical techniques - Lack of or inadequate procedures |
| Future Pak, Ltd. | Drugs | 10/15/2024 | Procedures not in writing, fully followed |
| Future Pak, Ltd. | Drugs | 10/15/2024 | Written procedures not established/followed |
| Future Pak, Ltd. | Drugs | 10/15/2024 | SOPs not followed / documented |
| Future Pak, Ltd. | Drugs | 10/15/2024 | Written in-process control procedures |
| Future Pak, Ltd. | Drugs | 10/15/2024 | Following/documenting laboratory controls |
| Future Pak, Ltd. | Drugs | 10/15/2024 | Investigations of discrepancies, failures |
| Future Pak, Ltd. | Veterinary | 10/15/2024 | Procedures not in writing, fully followed |
| Future Pak, Ltd. | Veterinary | 10/15/2024 | Written procedures not established/followed |
| Future Pak, Ltd. | Veterinary | 10/15/2024 | SOPs not followed / documented |
| Future Pak, Ltd. | Veterinary | 10/15/2024 | Written in-process control procedures |
| Future Pak, Ltd. | Veterinary | 10/15/2024 | Following/documenting laboratory controls |
| Future Pak, Ltd. | Veterinary | 10/15/2024 | Investigations of discrepancies, failures |
| Knickerbocker 365, Inc. | Food and Cosmetics | 05/31/2024 | Food safety plan - Preparation |
| Knickerbocker 365, Inc. | Food and Cosmetics | 05/31/2024 | Hazard analysis - Identification of hazard |
| Knickerbocker 365, Inc. | Food and Cosmetics | 05/31/2024 | Allergen preventive controls - Identify (Written) |
| Knickerbocker 365, Inc. | Food and Cosmetics | 05/31/2024 | Process preventive controls - Identify (Written) |
| Knickerbocker 365, Inc. | Food and Cosmetics | 05/31/2024 | Allergen preventive controls - Appropriate (Adequate) |
| LXR Biotech | Food and Cosmetics | 02/16/2024 | Equipment - automated - suitability |
| LXR Biotech | Food and Cosmetics | 02/16/2024 | Specifications - component identity |
| LXR Biotech | Food and Cosmetics | 02/16/2024 | Specifications-component purity, strength, composition |
| LXR Biotech | Food and Cosmetics | 02/16/2024 | Specifications - identity, purity, strength, composition |
| LXR Biotech | Food and Cosmetics | 02/16/2024 | Component - verify identity, dietary ingredient |
| LXR Biotech | Food and Cosmetics | 02/16/2024 | Component - confirm identity; specifications met |
| LXR Biotech | Food and Cosmetics | 02/16/2024 | Quality control - reject; specification not met |
| LXR Biotech | Food and Cosmetics | 02/16/2024 | Master manufacturing record theoretical and expected yield |
| LXR Biotech | Food and Cosmetics | 02/16/2024 | Master manufacturing record - sampling, tests, examinations |
| LXR Biotech | Food and Cosmetics | 02/16/2024 | Master manufacturing record - specific actions; quality |
| LXR Biotech | Food and Cosmetics | 02/16/2024 | Batch record - date, time; maintenance |
| LXR Biotech | Food and Cosmetics | 02/16/2024 | Batch record - identifier; labels |
| LXR Biotech | Food and Cosmetics | 02/16/2024 | Standard reference materials; criteria for selecting |
| LXR Biotech | Food and Cosmetics | 02/16/2024 | Examination, testing; scientifically valid |
| LXR Biotech | Food and Cosmetics | 02/16/2024 | Document; laboratory methodology followed |
| Ol Pharma Technician, LLC | Drugs | 07/22/2024 | Lack of quality control unit |
| Ol Pharma Technician, LLC | Drugs | 07/22/2024 | Procedures not in writing, fully followed |
| Ol Pharma Technician, LLC | Drugs | 07/22/2024 | Training--operations, GMPs, written procedures |
| Ol Pharma Technician, LLC | Drugs | 07/22/2024 | Equipment Design, Size and Location |
| Ol Pharma Technician, LLC | Drugs | 07/22/2024 | Cleaning / Sanitizing / Maintenance |
| Ol Pharma Technician, LLC | Drugs | 07/22/2024 | Control procedures to monitor and validate performance |
| Ol Pharma Technician, LLC | Drugs | 07/22/2024 | Scientifically sound laboratory controls |
| Ol Pharma Technician, LLC | Drugs | 07/22/2024 | Lack of written stability program |
| Ol Pharma Technician, LLC | Drugs | 07/22/2024 | Prepared for each batch, include complete information |
| Romd, LLC | Devices | 03/01/2024 | Training - Lack of or inadequate procedures |
| Woodward Pharma Services, LLC | Drugs | 03/28/2024 | Late submission of 15-day report |
| Woodward Pharma Services, LLC | Drugs | 03/28/2024 | Submission of report follow-up |
| Woodward Pharma Services, LLC | Drugs | 03/28/2024 | Failure to submit scientific article |
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