An Indian drugmaker has halted production of a couple of APIs for the U.S. after FDA inspectors found it was falsifying data at its manufacturing complex near Tamil Nadu, India. That was just the beginning of the problems.
The warning letter for Alchymars ICM was issued two weeks ago after a September inspection uncovered a host of problems including filthy areas, equipment that was badly in need of repair and a quality-control unit that had failed to inspect customer complaints thoroughly. Some of the observations were repeats from an inspection two years earlier.
The FDA acknowledged that the company had agreed to quit producing some products, bring in a consultant to help with data integrity and do a risk assessment of the products it has shipped to the U.S., but it was not enough to keep the FDA from issuing the warning letter. The FDA said the company clearly doesn’t know how to meet FDA standards.
“Repeated deficiencies demonstrate that your facility’s oversight and control over the manufacture of drugs is inadequate,” the warning letter said. “Because you failed to correct repeat deviations, we strongly recommend engaging a consultant qualified to evaluate your operations, and assist your firm in meeting CGMP requirements.”
Besides the need to get its data reporting in order, it said a consultant is needed to rework the water system in the complex. Inspectors noted that the company was drastically underreporting colony-forming units on media plates used to test water, including water used to make the API “for sterile injectable dosage forms.”
On top of that, washrooms often didn’t have hot water, soap, or hand-drying equipment, an issue that had been noted two years prior.