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 16.7% increase over the number of companies cited in the previous quarter.
Of the 18 citations issued, the most common citation was 'Procedures for corrective and preventive action have not been adequately established'.
Most of the companies cited were involved in the Devices 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 |
|---|---|---|---|
| Chitogen, Inc. | Devices | 03/19/2024 | Documentation |
| Chitogen, Inc. | Devices | 03/19/2024 | Lack of or inadequate procedures |
| Creganna Medical | Devices | 02/22/2024 | Training - Lack of or inadequate procedures |
| Desserts by Alighieri, Inc. | Food and Cosmetics | 02/09/2024 | Manufacturing, processing, packing, holding - Controls |
| Great Ciao, Inc. | Food and Cosmetics | 02/16/2024 | Importer verification |
| Medspira, LLC | Devices | 01/16/2024 | Lack of System for Event Evaluations |
| Medspira, LLC | Devices | 01/16/2024 | Design plans - Lack of or inadequate |
| Medspira, LLC | Devices | 01/16/2024 | Design validation - Risk analysis |
| Medspira, LLC | Devices | 01/16/2024 | Design changes - Lack of or Inadequate Procedures |
| Medspira, LLC | Devices | 01/16/2024 | Design history file |
| Medspira, LLC | Devices | 01/16/2024 | Nonconforming product, Lack of or inadequate procedures |
| Medspira, LLC | Devices | 01/16/2024 | Lack of or inadequate procedures |
| Medspira, LLC | Devices | 01/16/2024 | Lack of or inadequate complaint procedures |
| P. M. T. Corporation | Devices | 02/15/2024 | Design Validation - Risk analysis not performed/inadequate |
| P. M. T. Corporation | Devices | 02/15/2024 | Calibration, Inspection, etc. Procedures Lack of or Inadequ |
| P. M. T. Corporation | Devices | 02/15/2024 | Lack of or inadequate procedures |
| P. M. T. Corporation | Devices | 02/15/2024 | Investigation of device failures |
| ProMed Pharma, LLC | Devices | 02/21/2024 | Lack of or inadequate procedures |
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