Beanne was cited for cGMP violations including its failure to appropriately validate manufacturing processes, conduct any in-process testing, maintain laboratory raw data or use a stability testing program, according to the warning letter released Tuesday.
For example, the FDA says that during its inspection Beanne management said the company does not maintain records of raw data used to conduct analyses used “to ensure that the analyses were conducted correctly or that the results reported were within specifications.”
The firm’s management also “stated during the inspection that process validation, cleaning validation, and equipment qualification have not been conducted,” the FDA said.
The FDA sought a written response to all of the violations cited in the letter from Dec. 19, as well as documentation of validated cleaning methods for all shared equipment used in the manufacture of products shipped to the US. The agency also “strongly suggests [Beanne] perform a comprehensive assessment of manufacturing operations to ensure that they conform with cGMP.”
A spokesperson for Beanne told in-Pharmatechnologist.com that the company responded to the warning letter and is working to fix the issues cited in it.
Foreign Warning Letters
This is the second warning letter for a foreign manufacturer citing cGMP violations released by the FDA this year. The first was issued to Germany’s Hameln Pharmaceuticals and sent just two days before the Beanne letter was sent. In comparison, the agency sent only five warning letters to foreign facilities in all of 2008.
Foreign facilities in 2011 also saw more than 40 percent more GMP warning letters than in 2010.