Dr. Christine S. Lee Acting Associate Commissioner for Minority Health and Director of the Office of Minority Health and Health Equity (OMHHE) in the Office of the Commissioner at the U.S. FDA | Official Website
Dr. Christine S. Lee Acting Associate Commissioner for Minority Health and Director of the Office of Minority Health and Health Equity (OMHHE) in the Office of the Commissioner at the U.S. 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 in writing and fully followed.
- Procedures designed to prevent objectionable microorganisms in drug products not required to be sterile are not established.
- Drug products are not stored under appropriate conditions of temperature, humidity and light so that their identity, strength, quality, and purity are not affected.
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 |
|---|---|---|---|
| Coloplast Manufacturing US, LLC | Drugs | 04/11/2024 | Procedures not in writing, fully followed |
| Coloplast Manufacturing US, LLC | Drugs | 04/11/2024 | Procedures for non-sterile drug products |
| Coloplast Manufacturing US, LLC | Drugs | 04/11/2024 | Storage under appropriate conditions |
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