Regulatory Focus™ > News Articles > FDA Warns CMO’s Italy Site, Banned Indian API Manufacturer Over GMP Deficiencies

FDA Warns CMO’s Italy Site, Banned Indian API Manufacturer Over GMP Deficiencies

Posted 31 May 2016 | By Zachary Brennan 

FDA Warns CMO’s Italy Site, Banned Indian API Manufacturer Over GMP Deficiencies

Contract manufacturing organization (CMO) Corden Pharma’s Sermoneta, Italy-based site and Megafine’s active pharmaceutical ingredient (API) manufacturing site in Nashik, India, both received warning letters from the US Food and Drug Administration (FDA), which were released Tuesday.

For the Italian site, which produces both APIs and finished drugs, FDA’s inspection from last May (warning letter was sent 24 May 2016) uncovered sterility concerns, including visible “black grime and filth” in a sterile manufacturing area, as well as “cracked and inadequately repaired floor tiles.”

In addition, FDA found damaged, desiccated and cracked microbial plates that, according to FDA, “compromises microbial growth promotion and accurate enumeration, and may result in the underestimation of microbiological counts and false negatives.”

Corden also evaluated each type of plate damage and concluded that the effects of plate damage are negligible, though FDA says that the use of “deficient media fundamentally compromises the validity of your microbiological test results. Furthermore, you did not commit to stop using damaged plates for microbiological tests.”

On Friday, Corden acknowledged receiving the warning letter, saying: “CordenPharma Latina will respond with a comprehensive plan to address these observations within the stipulated time-frame of 15 days. The supply of any APIs and finished dosage forms from CordenPharma Latina to its customers will not be affected by this letter.”

Megafine

A day before FDA sent Corden its warning letter, the agency sent a warning letter to Megafine Pharma’s Nashik site, more than seven months after banning imports from the site.

The warning letter takes issue with Megafine’s inadequacies in addressing “the extent of the data falsification that could exist” in its laboratory.

“Multiple analysts, testing multiple drugs, deleted unknown peaks without justification. These manipulations made the drugs appear to meet their specifications,” FDA warned.

The agency is seeking a comprehensive investigation into the inaccuracies in Megafine’s data records and reporting, a risk assessment of the potential effect of the observed failures on the quality of drugs, an assessment of the risks to patients caused by the release of drugs affected by a lapse in data integrity and a global corrective and preventive action plan.

The site has also been certified by the World Health Organization, European Medicines Agency, Japan’s Pharmaceutical and Medical Devices Agency and Korean Food and Drug Administration, according to the company’s website.

Corden Pharma Warning Letter

Megafine Pharma Warning Letter


Categories: Regulatory News

Regulatory Focus newsletters

All the biggest regulatory news and happenings.

Subscribe