CordenPharma Receives FDA Warning Letter

On May 27, 2016, CordenPharma notified customers about a warning letter the company received from FDA for its CordenPharma Latina facility in Sermoneta, Italy. The warning letter follows an inspection of the site by FDA in early May 2015, the company said in the statement.

The FDA warning letter cited several CGMP violations for finished pharmaceuticals and APIs. Some of these violations include visible “black grime and filth” in the aseptic area. Other violations included failure to sanitize equipment at appropriate intervals, failure to establish laboratory controls, unsound test procedures to test API quality, and a facility not designed to limit exposure to microbiological contamination. 

The company said it will respond with a “comprehensive plan” to address FDA’s observations within 15 days. The company also noted the supply of any APIs and finished dosage forms will not be affected by the warning letter. The company said it will contact customers within the next 10 days to address the effects of the letter and highlight its response.

Source: CordenPharma, FDA