FDA warning letter tells India's Goran Pharma to get professional help

fda
The FDA has issued a warning letter to Indian drugmaker Goran Pharma Private Ltd. for problems at its plant in Sihor, Gujarat. (FiercePharma)

The FDA has slapped a warning letter on an Indian drugmaker after first banning its products following an inspection that found it was not meeting some of the most basic FDA manufacturing standards.

The letter was issued late last month to the Goran Pharma Private Ltd. plant in Sihor, Gujarat. The letter followed a brief inspection last November that tallied up a list of GMP failures. It also came about two months after the agency put the Goran plant on the FDA import alert list (PDF).

Whitepaper

Simplify and Accelerate Drug R&D With the MarkLogic Data Hub Service for Pharma R&D

Researchers are often unable to access the information they need. And, even when data does get consolidated, researchers find it difficult to sift through it all and make sense of it in order to confidently draw the right conclusions and share the right results. Discover how to quickly and easily find, synthesize, and share information—accelerating and improving R&D.

The FDA was particularly disturbed that the Indian drug company had not given its quality unit the authority to review products before they were shipped to clients. The letter said batches were released without the unit first checking production and control records, and even before microbial test had been completed.

“Significant findings in this letter indicate that your quality unit is not fully exercising its authority and/or responsibilities,” the FDA said. “Your firm must provide the quality unit with the appropriate authority, sufficient resources and staff to carry out its responsibilities and consistently ensure drug quality.”

The agency also nicked the plant for not testing suppliers’ ingredients to ensure they were safe and met standards. It was concerned about deficient laboratory controls including how media was stored and a lack of growth promotion testing that would reliably detect bioburden or microbial limits failures.

Goran responded with a list of good intentions, but the FDA was not satisfied by those promises. It suggested the drug facility get professional help from a consultant.

Suggested Articles

Sanofi, which has moved purposefully into high technologies to get more from its manufacturing, will lean even more on that strategy to save costs.

Just months after a C-suite shakeup at Amneal, the generics company has struck a $220 million deal for AvKare, known on the street as R&S Northeast. 

Fujifilm has completed the first manufacturing facility in Japan to make drug-delivering liposomes to use for cancer fighting drugs it is developing.