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 a 100% increase over the number of companies cited in the previous quarter.
The citations in the county include:
- You did not establish and maintain procedures for testing and screening of HCT/P donors.
- The eligibility of an HCT/P donor was not determined and documented by a responsible person, based on results of donor screening and donor testing.
- Documentation of the responsible person who made the donor-eligibility determination was not maintained.
Both companies cited were involved in either Biologics or Drugs sectors.
Of the companies cited, one should take voluntary action to correct its managing operations (50%). Additionally, one company had to take regulatory and/or administrative actions (50%).
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 |
|---|---|---|---|
| Granules Pharmaceuticals, Inc. | Drugs | 12/15/2023 | Procedures not in writing, fully followed |
| Granules Pharmaceuticals, Inc. | Drugs | 12/15/2023 | Rejected Material Area |
| Granules Pharmaceuticals, Inc. | Drugs | 12/15/2023 | Buildings not maintained in good state of repair |
| Granules Pharmaceuticals, Inc. | Drugs | 12/15/2023 | Equipment Design, Size and Location |
| Granules Pharmaceuticals, Inc. | Drugs | 12/15/2023 | Cleaning / Sanitizing / Maintenance |
| Washington Fertility Center | Biologics | 11/02/2023 | Testing, screening, donor eligibility procedures |
| Washington Fertility Center | Biologics | 11/02/2023 | Responsible person to determine, document |
| Washington Fertility Center | Biologics | 11/02/2023 | Documentation--determination, by whom, date |
| Washington Fertility Center | Biologics | 11/02/2023 | Risk factors, clinical evidence |
| Washington Fertility Center | Biologics | 11/02/2023 | Infection with communicable disease agents |
| Washington Fertility Center | Biologics | 11/02/2023 | Eligibility not required--warning labels |
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