'All Clear' at ABC Laboratories following FDA, EPA inspections

The two ABC Laboratories, Inc. facilities in Columbia, Missouri, passed inspection by the U.S. Food and Drug Administration (FDA) earlier this month with flying colors.

The FDA's inspection covered ABC’s synthesis operations at ABC Lane and its Discovery Ridge location, which performs all other pharmaceutical analytical services for the company. The FDA inspection took five days and the company got a clean bill of health – no Form 483s issued and no verbal observations were made.

The week before the FDA review, the company had an inspection visit from the U.S. Environmental Protection Agency, which ended with no observations.

“Regulatory inspections provide a great opportunity for our organization to demonstrate the rigor with which we address regulatory compliance every hour of every day,” John D. Bucksath, ABC president and CEO, said. “I think it is uncommon for ABC or any laboratory to be inspected by both agencies back-to-back, but I was confident that ABC’s quality systems and processes would stand up to regulatory scrutiny. I am very proud of our team.”

ABC Laboratories is a privately held research organization that provides development and analytical testing services to the pharmaceutical, biopharmaceutical, animal health, crop protection and chemical industries.

Organizations in this story

U.S. Environmental Protection Agency (EPA) 1200 Pennsylvania Ave NW Washington, DC - 20460

Get notified the next time we write about U.S. Environmental Protection Agency (EPA)!