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 month.
The citations in the county include:
- The responsibilities and procedures applicable to the quality control unit are not fully followed.
- Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design to facilitate operations for its intended use.
- 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.
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.
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 |
---|---|---|---|
Nitro Quimica Corporation | Drugs | 02/21/2025 | Procedures not in writing, fully followed |
Nitro Quimica Corporation | Drugs | 02/21/2025 | Equipment Design, Size and Location |
Nitro Quimica Corporation | Drugs | 02/21/2025 | Written procedures not established/followed |
Nitro Quimica Corporation | Drugs | 02/21/2025 | Reprocessing procedures not written or followed |
Nitro Quimica Corporation | Drugs | 02/21/2025 | Storage under appropriate conditions |