Pointed references to repeat violations characterize three GMP warning letters posted by the FDA this week. Repeat offenses are a sore spot with the regulator and increasingly cited in its references to executive prosecutions.
The warnings were issued to Contract Pharmacal in New York, Kyowa Hakko Kogyo Co. in Yamaguchi, Japan, and Qualiphar in Bornem, Belgium.
Contract Pharmacal leads the pack with four such references in Warning Letter NYK-2011-03. Inadequate written procedures for production and process controls, cited in the current letter, is a repeat observation from inspections in 2000 and 2006. Poor batch failure investigation is another repeat, going back to a 2008 inspection. Incorrect product expiration date calculations were a problem in the 2006 inspection and are again. Finally, lack of written procedures for out-of-spec sampling and other matters were violations in 2006 and in the current warning.
For Kyowa Hakko Kogyo in WL: 320-10-009, there's one repeat: lack of a control system for lab records, which was cited following a 2007 inspection. The lab uses no bound notebooks or uniquely identified worksheets controlled by the quality unit for the recording of raw data. The company had addressed the matter in 2007, but for the specific example cited. "Your correction was not applied globally to all areas in which original raw data should be recorded and retained," the letter says.
Qualiphar in Belgium, cited for inadequate written procedures for production and process control in Warning Letter 320-10-11, was similarly cited in 1998 and 2002. In addition, the regulator notes that its May 2010 inspection marked the third time that investigators found that its facility stopped manufacturing particular products prior to the visit.