Leah Hunter Commissioner for External Affairs (OEA) within the Office of the Commissioner at the U.S. Food and Drug Administration | Official Website
Leah Hunter Commissioner for External Affairs (OEA) within the Office of the Commissioner at the U.S. Food and Drug Administration | Official Website
This is an increase over the number of companies cited in the previous quarter.
The citations in the county include:
- The responsibilities and procedures applicable to the quality control unit are not in writing.
- GMP training is not conducted with sufficient frequency to assure that employees remain familiar with CGMP requirements applicable to them.
- Equipment and utensils are not maintained at appropriate intervals to prevent malfunctions that would alter the safety, identity, strength, quality or purity of the 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.
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 |
|---|---|---|---|
| Messer, LLC | Drugs | 03/06/2024 | Procedures not in writing, fully followed |
| Messer, LLC | Drugs | 03/06/2024 | GMP Training Frequency |
| Messer, LLC | Drugs | 03/06/2024 | Cleaning / Sanitizing / Maintenance |
| Messer, LLC | Drugs | 03/06/2024 | Review of representative number of batches |
| Messer, LLC | Drugs | 03/06/2024 | Investigations of discrepancies, failures |
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