It has been a little over a year now that inspectors from the FDA have been returning to a normal overseas inspection workload. What they are finding is not pretty.
India is the number one source of numerous pharmaceuticals sold to the U.S. It is a massive producer of active pharmaceutical ingredients (API) that get turned into pills and liquid injectables used by American patients. In the latest, India’s leading producer of psychotropic drugs, Centaur Pharmaceuticals, got a Warning Letter after inspectors gave them poor marks for data integrity and – even worse – cleanliness.
Inspectors uncovered analytical worksheets, incident report forms, batch release copies and other production documents stored in laboratory drawers and cabinets with “unrestricted access and inadequate controls.” The FDA said in their letter that some original manufacturing documents were “discarded and shredded without a review and a meaningful description in the logbook.”
The Warning Letter was dated June 5.
Centaur Pharmaceuticals responded to the cleanliness issue, citing the discovery of residue material found on machines used to make drugs was “non-reactive” – meaning it would not contaminate the products. But the FDA said their response was “inadequate” and that they failed to clean equipment and utensils in a way that would prevent contamination of the company’s API sold here.
Centaur makes antipsychotic and antidepressant generics like Flupentixol and Nortriptyline. It also makes strong drugs like Temazepam, a hypnotic used to treat severe insomnia patients.
Warning Letters are given to labs to put in place a series of remedial actions the company must take if it wants to maintain access to the U.S. market and registration as an FDA approved facility. They do not necessarily lead to import restrictions. That means that despite the “dirty lab” write-up by the inspectors in June, Centaur can still sell medication to the U.S.
Oddly enough, this is the second time in less than a year that FDA inspectors found Indian companies that threw away, or shredded, documents about how their drugs were produced. These are supposed to be maintained for inspectors as part of the FDA’s Current Good Manufacturing Practices.
Last year, Intas Pharmaceuticals was caught doing the same thing, with FDA inspectors actually having to rummage through their trash, as the New York Times reported in May.
As a result, an Intas Pharmaceuticals lab in Ahmedabad was put on Import Alert, meaning it could not sell drugs to the United States.
Still, despite that Alert, the FDA said in a letter dated June 2 that 25 drugs in short supply in the United States would still be allowed access.
We are a group of doctors, patients, health care industry experts, and advocates fighting to ensure all generic medicines are safe, affordable, and always available. Unsafe generic drugs from foreign manufacturers in China and India have been sold in the U.S that have been contaminated with carcinogens and fake ingredients, fall apart when tested, and don’t work as they should. We are fighting back to ensure all generic medicines are safe, affordable, and always available. We want every American to be able to trust the generics they take—every pill, every vial, every time.