Dr. Namandjé N. Bumpus Principal Deputy Commissioner - FDA | Official Website
Dr. Namandjé N. Bumpus Principal Deputy Commissioner - FDA | Official Website
This is a 42.9% increase over the number of companies cited in the previous year.
Of the 33 citations issued, the most common citations were 'Your hazard analysis did not identify a hazard that required a preventive control' and 'Procedures for corrective and preventive action have not been adequately established'.
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 the Devices sector.
Of the companies cited, nine should take voluntary actions to correct their managing operations (90%). Additionally, one company had to take regulatory and/or administrative actions (10%).
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 |
---|---|---|---|
APS Materials, Inc. | Devices | 03/15/2023 | Rationale documented for no investigation |
BNG Miracle Pet, LLC | Veterinary | 10/10/2023 | Hazard Analysis |
BNG Miracle Pet, LLC | Veterinary | 10/10/2023 | Preventive Controls |
BNG Miracle Pet, LLC | Veterinary | 10/10/2023 | Adequacy of Corrective Actions Implemented |
BNG Miracle Pet, LLC | Veterinary | 10/10/2023 | Validation of Process or Other Preventive Control |
Basic Drugs, Inc. | Food and Cosmetics | 05/30/2023 | Specifications - product received for packaging, labeling |
Basic Drugs, Inc. | Food and Cosmetics | 05/30/2023 | Reserve sample - twice the quantity |
Basic Drugs, Inc. | Food and Cosmetics | 05/30/2023 | Written procedure quality control operations material review |
Basic Drugs, Inc. | Food and Cosmetics | 05/30/2023 | Master manufacturing record - each batch |
Basic Drugs, Inc. | Food and Cosmetics | 05/30/2023 | Batch record - complete |
Basic Drugs, Inc. | Food and Cosmetics | 05/30/2023 | Written procedures - holding |
Basic Drugs, Inc. | Food and Cosmetics | 05/30/2023 | Product complaint - quality control review |
Basic Drugs, Inc. | Food and Cosmetics | 05/30/2023 | Quality control - processes, specifications, written procedures |
Cassanos, Inc. | Food and Cosmetics | 08/24/2023 | Personnel |
Cassanos, Inc. | Food and Cosmetics | 08/24/2023 | Hazard analysis - Identification of hazard |
Cassanos, Inc. | Food and Cosmetics | 08/24/2023 | Process preventive controls - Appropriate (Adequate) |
Dorothy Lane Market, Inc. | Food and Cosmetics | 09/22/2023 | Hazard analysis - Identification of hazard |
Johnson Medtech, LLC | Devices | 11/27/2023 | Production processes |
Johnson Medtech, LLC | Devices | 11/27/2023 | Documentation |
Johnson Medtech, LLC | Devices | 11/27/2023 | Acceptance status |
Johnson Medtech, LLC | Devices | 11/27/2023 | Lack of or inadequate procedures |
Malt Products Corporation | Food and Cosmetics | 02/24/2023 | Sanitation preventive controls - Implement |
Milanos Bread, LLC | Food and Cosmetics | 01/27/2023 | Sanitary operations - Plant maintenance |
Milanos Bread, LLC | Food and Cosmetics | 01/27/2023 | Sanitary operations - Plant sanitation |
Milanos Bread, LLC | Food and Cosmetics | 01/27/2023 | Sanitation of food-contact surfaces - Frequency |
Milanos Bread, LLC | Food and Cosmetics | 01/27/2023 | Equipment and utensils - Design and maintenance |
Mirac, LLC | Devices | 05/11/2023 | Quality audits - auditor independence |
Mirac, LLC | Devices | 05/11/2023 | Lack of or inadequate process validation |
Mirac, LLC | Devices | 05/11/2023 | Nonconforming product, Lack of or inadequate procedures |
Mirac, LLC | Devices | 05/11/2023 | Lack of or inadequate procedures |
Mirac, LLC | Devices | 05/11/2023 | Lack of or inadequate complaint procedures |
Steven D. Folkerth, M.D. | Drugs | 01/13/2023 | FD-1572, protocol compliance |
Steven D. Folkerth, M.D. | Drugs | 01/13/2023 | Accountability records |