ABC Announces Completion of FDA GMP Inspection

COLUMBIA, Mo.--()--ABC Laboratories announced today that a GMP facility inspection conducted by the United States Food and Drug Administration (FDA) at both Columbia facilities was completed Friday, March 6. The general GMP facilities inspection included ABC’s Synthesis operations at ABC Lane as well as its Discovery Ridge location where all other GMP pharmaceutical analytical services are performed. At the conclusion of the 5-day inspection, no FDA Form 483 was issued, and no verbal observations were issued. This inspection follows last week’s 4-day GLP inspection from the U.S. Environmental Protection Agency (EPA), which also concluded 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,” said John D. Bucksath, ABC President & CEO. “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.”

About ABC Laboratories

Analytical Bio-Chemistry (ABC) Laboratories, Inc. is a privately held Contract Research Organization that provides expert development and analytical testing services to the pharmaceutical, biopharmaceutical, animal health, crop protection and chemical industries. The company helps its clients expedite time-to-market by devising phase-appropriate development strategies, and supports all stages of product development, registration and commercialization with a broad range of GLP- and CGMP-compliant testing, including custom synthesis, radiolabeling and environmental assessments. ABC employs more than 400 scientists and support personnel, and has its headquarters in Columbia, Missouri.

For additional information, visit http://www.abclabs.com.

Contacts

ABC Laboratories
Kristein King, 573-777-6209

Release Summary

ABC Laboratories announced today a 5-day GMP facility inspection conducted by the FDA has been completed. No FDA Form 483s or verbal observations were issued. This follows last week's EPA inspection.

Contacts

ABC Laboratories
Kristein King, 573-777-6209