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).
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.