- Czech drugmaker Interpharm Praha, which ships both finished products and active pharmaceutical ingredients to the U.S., has landed in hot water with the Food and Drug Administration, according to a warning letter posted to the regulator's website this week.
- The FDA, which inspected Interpharm's plant in Modrany, Czech Republic last fall, flagged glaring failures in the firm's data controls and laboratory procedures.
- Finding Interpharm's initial response unsatisfactory, the FDA demanded the company conduct a comprehensive investigation and risk assessment, and detail a global corrective action plan.
While the FDA regularly warns API and drug manufacturers in India and China, warnings issued to European firms are less common.
So far in 2016, the agency has cited 19 companies located in either India or China for CGMP failings, while the warning to Interpharm is only the seventh such letter sent to companies with facilities based in Europe. (One recent letter was sent to the Israeli Teva Pharmaceuticals related to its site in Hungary.)
In the case of Interpharm, the FDA found the company's quality control unit failed to put in place controls preventing other staff from making changes to laboratory data on APIs. This type of problem frequently trips up manufacturers, but the FDA was more explicit than usual in detailing the violations.
"During the inspection, we reviewed an audit trail from your Empower-2 system that stored 8,906 entries. Of these, well over half indicated some form of data deletion or manipulation, including at least 1,441 instances of deleted results, at least 3,643 instances of manual integration, and at least 194 instances of altered running sample sets," the letter said.
This meant Interpharm's quality unit had incomplete and inaccurate information on the quality of the company's drugs before it signed off on batch releases.
FDA inspectors also noted Interpharm's procedures allowed analysts to make improper modifications to chromatographic sequences for both API and finished products.