Jim Jones Deputy Commissioner for Human Foods of FDA | Official Website
Jim Jones Deputy Commissioner for Human Foods of FDA | Official Website
This is an increase over the number of companies cited in the previous quarter.
The citations in the county include:
- Control procedures are not established which monitor the output and validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product.
- Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not written and followed.
- There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed.
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.
According to its website, 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.
| Company Name | Area of Business | Inspection Date | Issue Cited |
|---|---|---|---|
| Hospira, A Pfizer Company, Inc. | Drugs | 01/17/2025 | Control procedures to monitor and validate performance |
| Hospira, A Pfizer Company, Inc. | Drugs | 01/17/2025 | Procedures for sterile drug products |
| Hospira, A Pfizer Company, Inc. | Drugs | 01/17/2025 | Investigations of discrepancies, failures |
Alerts Sign-up