"We are particularly concerned with your firm's failure to implement a robust Quality System. Repeat citations...indicate that your quality control unit is not exercising its responsibilities, and may not have the appropriate authority." So states Warning Letter 320-11-016, to Jelfa board President Marek Wojcikowski.
This warning combines the 2011 trends of more references to repeat offenses, more foreign plant inspections, and a terse tone.
The Jelenia Gora, Poland, company received FDA visitors in October 2010. The warning was issued last July. "We note that the CGMP violations listed in this letter include similar violations to those cited in the previous inspection in February 2008, and in our letter to you dated July 17, 2008," the letter says.
Among the three counts cited is the QC unit's absence from the process of approving "procedures or specifications that may impact the identity, strength, quality, and purity of the drug product." In addition, company procedures appear to give the QC unit no active role in the oversight of media fill studies.
"We recommend you engage a third party consultant having appropriate CGMP expertise," the letter says. "We remind you that it is your responsibility to implement sustainable corrective actions."