McNeil Consumer Health Care draws steps to remedy serious quality and safety lapses at their manufacturing facilities. They have been under investigation by the Food and Drug Administration due to the recalls they made for their over-the-counter drugs – Tylenol, Motrin and Benadryl. The company said in a statement, “McNeil is taking steps to bring its operation back to a level of quality that Johnson & Johnson demands of its companies, and that the public rightly expects of us, that we expect of ourselves.”
The steps include hiring an independent pharmaceutical consulting firm to identify corrective actions to improve quality and manufacturing systems at its Fort Washington facility. The company stated that they are also improving employee training in every part of the manufacturing and quality operations, and implementing new processes for conducting investigations on quality levels. They also stated that they have made organizational changes, however it was not specified. They also stated that they are working with an independent consultant on specific steps to improve overall quality which was termed as “remediation” period. There will also be a remediation committee responsible for implementing the plan for the plant and monitoring its effectiveness.
The FDA will be updated by the company on the progress of their plan for a month. There would also be an independent firm to help the company in making product decisions for the first months of the operation. McNeil said that they will conduct in-depth quality assessments for each product that the company manufactures to “ensure each product’s ability to meet specifications throughout its shelf life.”
Related posts:
- Tylenol Recall 2010 by McNeil Consumer Healthcare
- Bacterial Contamination in J&J’s medication for children
- Congress Investigates Johnson & Johnson