FDA slaps Indian API maker in warning letter

The FDA has issued a warning letter to Indian API maker Resonance Laboratories over cleanliness concerns.

In a warning letter, the FDA showed its dissatisfaction with manufacturing at an Indian API plant in Bangalore for falling short of standards of cleanliness.

The letter was issued to Resonance Laboratories on Feb. 3, after an inspection in May of last year uncovered problems. The FDA posted the letter this week, saying the responses to the corrections the API maker provided to the agency lacked the details needed for the FDA to find them acceptable.

One problem was that the company couldn’t show that the “distilled water” it uses to clean equipment downstream of the purification steps is suitable for use. The FDA raised questions when it found that even after passing through a micrometer filter, distilled water used for cleaning equipment in cleanrooms had “an unacceptable level of bioburden.”

The drugmaker was using the same equipment for the manufacture of different APIs, but tests showed that after equipment was cleaned it often failed the company’s own measures for the residual drug. Instead of finding a better solution to the problem, the company repeated the same process until it reported passing results, the FDA said.

The FDA suggested Resonance hire a consultant to help achieve FDA standards.

Indian plants continue to rack up a significant number of warning letters but not as many as Chinese facilities. A review of the 42 warning letters issued by the FDA’s office of Manufacturing Quality in 2016 showed that Indian-owned facilities were issued nine—including one for a manufacturer in the U.K. owned by India’s Wockhardt, the only company to receive two warning letters last year—while Chinese companies received 14. The FDA focused more of its attention on China, a major supplier of APIs globally.