Dr. Namandjé N. Bumpus Principal Deputy Commissioner - FDA | Official Website
Dr. Namandjé N. Bumpus Principal Deputy Commissioner - FDA | Official Website
This is unchanged from the number of companies cited in the previous month.
The citations in the county include:
- The responsibilities and procedures applicable to the quality control unit are not in writing.
- Written procedures are not followed for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product.
- Establishment of the reliability of the component supplier's report of analyses is deficient in that the test results are not appropriately validated at appropriate intervals.
The company cited should take a voluntary action to correct its 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 |
|---|---|---|---|
| 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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