While active pharmaceutical ingredient (API) producers from China and India are often seen as the most likely culprits for missing cGMP standards in production, that doesn’t mean Western companies are free from issues. The FDA has now sent a warning letter to an API producer in Germany that the agency says has a host of production problems.
The FDA posted a letter on Tuesday that has been issued to BBT Biotech for a plant in Baesweiler, Germany, after an inspection in May 2015 left inspectors concerned about production processes there.
The FDA said the firm has shipped APIs to the U.S. since 2012 on which it had done no stability testing to support the expiration dates it put on its products.
BBT also was not having its quality unit review or approve changes in suppliers, so there was no assurance that ingredients it used met FDA standards. Inspectors pointed to the problems that can lead to because BBT blamed an out-of-spec test result for a lot on a change in supplier. The FDA said the company was not adequately investigating out-of-spec issues because it did not evaluate other lots made with the ingredient from that supplier.
The inspectors also cited the facility for lacking access controls and audit trail capabilities on computerized systems. It pointed out that all employees had administrator privileges and shared one user name, so actions could not be attributed or traced to specific individuals and there was no guarantee that employees would not manipulate or delete data.
The agency gave the company a list of fixes it expected from the plant and warned it may restrict products until they are in place and approved.
The FDA and European regulators have stepped up inspections and actions, and companies from India and China, which make the vast majority of the API and generic drugs sold in the U.S., have often been the recipients of actions. Just last month, the FDA filed a warning letter against India's Sri Krishna Pharmaceuticals, and last week, EU regulators announced actions against India’s JP Laboratories unit in Maharashtra and a Krebs Biochemicals & Industries plant in Andhra Pradesh. This had led some in the Indian pharma industry to suggest that Western regulators are biased against them.
But the FDA and the EU have also filed actions against European and U.S. companies. In recent weeks, the European Medicines Agency has taken actions against companies in Spain, France and even in the U.S. Earlier this month, at the suggestion of inspectors from Sweden, the agency banned products from Capsugel’s Bend Research facility in Oregon over what it termed “Repeated failures.”
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