Benjamin D. Moncarz Chief Financial Officer - FDA | Official Website
Benjamin D. Moncarz Chief Financial Officer - FDA | Official Website
This is an increase over the number of companies cited in the previous quarter.
The citations in the county include:
- Environmental conditions existed in which contamination or cross contamination of HCT/Ps or equipment could occur, and environmental conditions were not adequately controlled.
- Environmental controls do not provide for adequate control of humidity.
- Environmental controls do not provide for adequate cleaning and disinfecting of rooms and equipment to ensure aseptic processing.
The company cited was involved in the Biologics 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 |
|---|---|---|---|
| WuXi AppTec, Inc. | Biologics | 05/02/2024 | Adequate control, proper conditions |
| WuXi AppTec, Inc. | Biologics | 05/02/2024 | Temperature and humidity controls |
| WuXi AppTec, Inc. | Biologics | 05/02/2024 | Aseptic processing---cleaning, disinfecting |
| WuXi AppTec, Inc. | Biologics | 05/02/2024 | Monitoring-microorganisms where appropriate |
| WuXi AppTec, Inc. | Biologics | 05/02/2024 | Procedures inadequate |
| WuXi AppTec, Inc. | Biologics | 05/02/2024 | In-house reagent production |
| WuXi AppTec, Inc. | Biologics | 05/02/2024 | Design of labeling procedures |
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