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 unchanged from the number of companies cited in the previous month.
The citations in the county include:
- Equipment and utensils are not maintained at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product.
- 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.
- Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to assure that in-process materials and drug products conform to appropriate standards of identity, strength, quality and purity.
The company cited was involved in the Drugs sector.
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 |
|---|---|---|---|
| Genentech, Inc. | Drugs | 04/19/2024 | Cleaning / Sanitizing / Maintenance |
| Genentech, Inc. | Drugs | 04/19/2024 | Written procedures not established/followed |
| Genentech, Inc. | Drugs | 04/19/2024 | Scientifically sound laboratory controls |
| Genentech, Inc. | Drugs | 04/19/2024 | Establishment of calibration procedures |
| Genentech, Inc. | Drugs | 04/19/2024 | Master production and control records, procedure |
| Genentech, Inc. | Drugs | 04/19/2024 | Written record of investigation incomplete |
| Genentech, Inc. | Drugs | 04/19/2024 | Testing Calculations |
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