Arkansas Compounder Warned for Nonsterile Conditions

The FDA has warned an Arkansas compounder for multiple GMP violations, including failing to ensure the sterility of the drugs it produced.

Cantrell Drug Company lacked written procedures for producing sterile drugs and any system for monitoring the environmental conditions of its aseptic processing areas, according to a Jan. 21 warning letter released recently.

The company also lacked a system for cleaning and disinfecting rooms and equipment used in sterile manufacturing and failed to demonstrate that equipment hoods actually protect drugs from contamination.

Further, the company, which registered as an FDA-regulated outsourcing facility in December 2013, produced drugs without valid prescriptions for individual patients before registering, a violation of the law, the letter notes.

The warning letter followed an Oct. 15 through Nov. 4, 2013, inspection of Cantrell’s Little Rock, Ark., facility.

In responding to the FDA’s criticisms, the company said it adheres to USP regulations on pharmaceutical compounding and sterile preparations regarding gowning practices and sterility testing. And it proposed a series of corrective actions, including media fill studies to validate its aseptic processes.

While some of the firm’s corrective actions appeared adequate, the FDA said, others, including the media fill studies, were deficient.

The FDA noted, for example, that Cantrell’s media fill studies didn’t include worst-case scenarios and challenging conditions. Moreover, in manually intensive filling processes, the number of units in the study should approach the full production batch size, the letter says.

Stay up to date with data integrity stories like this one by subscribing to Drug GMP Report. For over 20 years, drug manufacturers have relied on DGR for the latest on FDA’s interpretation and enforcement of cGMPs and the Quality Systems Regulation — information you need to stay in compliance.