A Czech drugmaker that ships both APIs and finished products to the U.S. has come under fire from the FDA in a warning letter for data integrity issues that the agency says leave questions about the quality of the company’s drugs. It listed about a dozen steps it wants the company to take to improve its systems, suggesting it bring in an expert to help get its operations in order.
The warning letter to Interpharm Praha was posted this week, more than a year after the FDA’s October 2015 inspection of the plant in Modrany, Czech Republic. The agency issued observations for both API and finished product violations, but most of them centered on big problems it found in the company’s data collection and reporting.
The FDA said because of lack of controls and the routine purging of data by analysts, the company’s quality-control unit does not have all of the info it needs to make informed decisions about whether products are safe and effective and meet the standards for sale in the U.S.
In just one of a number of examples, the FDA letter points to an audit trail for API production in which well over half of the 8,906 entries indicated some kind of data deletion or manipulation, including at least 1,441 instances in which results were deleted. Inspectors found another 3,643 instances of manual integration and at least 194 instances of “altered running sample sets.” The letter said plant personnel acknowledged that this kind of data deletion and altering was commonplace at the plant.
The letter said many of the same kinds of problems were discovered in finished product production and pointed out that "deleted and altered analytical test results mean that your quality unit is presented with incomplete and inaccurate information about the quality of your drugs.”
Data deletion and manipulation has been a frequent problem cited in FDA warning letters in recent years, often with Indian and Chinese drugmakers. Some of India’s largest drugmakers including Wockhardt, Sun Pharmaceutical and Ranbaxy Laboratories, now owned by Sun, have received warning letters in which data manipulation and deletion was cited, as have a number of large and small Chinese drugmakers.