FDA Warns Turkish Drugmaker Over Penicillin Cross-Contamination Issues
Posted 19 August 2019 | By
The US Food and Drug Administration (FDA) warned Turkish drugmaker Deva Holding AS earlier this month over good manufacturing practice (GMP) violations at the company’s Tekirdağ manufacturing site.
The warning letter comes after a two-week inspection in February that identified a risk of penicillin cross-contamination between two adjacent campuses.
In July, FDA placed Deva on Import Alert and the company initiated a voluntary recall for all batches of six strengths of temozolomide capsules, a chemotherapy drug used to treat glioblastoma and anaplastic astrocytoma, due to the risk of penicillin cross-contamination.
According to the warning letter, Deva manufactures penicillin and other drug products in two campuses, Cerkezkoy 1 and 2, which are a quarter mile (0.4km) apart, with a product intended for the US market made at the Cerkezkoy 2 campus.
FDA says the company detected the presence of penicillin outside the penicillin manufacturing areas more than 150 times from 2017 through June 2019, including in the material acceptance ramp and personnel entrance area of the building where products intended for the US market are made.
“Your facility and controls to prevent contamination of non-penicillin drugs with penicillin are inadequate. Contamination of non-beta-lactam drugs with beta-lactam drugs presents great risk to patient safety, including potential anaphylaxis and death. No safe level of penicillin contamination has been determined to be a tolerable risk,” FDA writes.
FDA says Deva’s routine monitoring for penicillin in non-penicillin production areas was inadequate as the company did not monitor the production area where products meant for the US market were made. FDA notes that the firm began monitoring for penicillin in those production areas after being placed on Import Alert.
Additionally, FDA says Deva did not have data demonstrating that the solutions used to decontaminate penicillin throughout its facilities are effective.
FDA also says the company did not test its non-penicillin drug products for penicillin contamination “despite the known possibility for cross-contamination” and that the company’s new method for testing for penicillin contamination “is not sufficiently sensitive to detect very low levels of contamination.”