India’s Indoco Remedies thought it was on the right track with its corrective action plan after an FDA inspection nailed a sterile and solid dosage manufacturing site with half a dozen observations last fall. But concerns over a couple of those has resulted in the drugmaker being served with an FDA warning letter.
The drugmaker announced (PDF) last week that the FDA had issued it a warning letter for its plant in Goa.
The FDA had inspected the plants in late August as part of an abbreviated new drug application for an injectable product, but instead of a clean bill of health, the agency issued a Form 483 with the 6 observations.
Indoco said in a letter to the Bombay Stock Exchange that, based on the review of compliance response, the FDA was satisfied with its response to four of the observations. But the agency still had problems tied to two observations that have to do with a specific product the drugmaker is making for a client and it was those concerns that led to last week’s warning letter.
Execs said in a conference call that the product in question is the opthalmic drug Latanoprost, Bloomberg reports, a drug for which the company generates about Rs 25 crore ($3.8 million) a year. The company said it is hiring consultants to help it deal with the FDA’s concerns. Officials said the U.S. accounts for about 10% of the company’s overall sales.