Dr. Namandjé N. Bumpus Principal Deputy Commissioner - FDA | Official Website
Dr. Namandjé N. Bumpus Principal Deputy Commissioner - FDA | Official Website
This is an increase over the number of companies cited in the previous quarter.
Of the 14 citations issued, the most common citation was 'Individuals who conduct quality audits have direct responsibility for the matters being audited'.
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 |
|---|---|---|---|
| Electronic Manufacturing Services Group, Inc. | Devices | 03/08/2024 | Management representative |
| Electronic Manufacturing Services Group, Inc. | Devices | 03/08/2024 | Quality audits - auditor independence |
| Electronic Manufacturing Services Group, Inc. | Devices | 03/08/2024 | Lack of or inadequate complaint procedures |
| Oakworks, Inc. | Devices | 01/17/2024 | Management review - defined interval, sufficient frequency |
| Oakworks, Inc. | Devices | 01/17/2024 | Quality audits - auditor independence |
| Oakworks, Inc. | Devices | 01/17/2024 | Design verification - documentation |
| Oakworks, Inc. | Devices | 01/17/2024 | Design validation - simulated testing |
| Oakworks, Inc. | Devices | 01/17/2024 | Lack of or inadequate procedures |
| Oakworks, Inc. | Devices | 01/17/2024 | Complaints |
| Sulzbach Enterprises, Inc. | Veterinary | 02/01/2024 | Procedures not in writing, fully followed |
| Sulzbach Enterprises, Inc. | Veterinary | 02/01/2024 | Written procedures not established/followed |
| Sulzbach Enterprises, Inc. | Veterinary | 02/01/2024 | Establish reliability of supplier's C of A |
| Sulzbach Enterprises, Inc. | Veterinary | 02/01/2024 | Establishment of time limitations |
| Sulzbach Enterprises, Inc. | Veterinary | 02/01/2024 | Test methods |
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