U.S. FDA Flags Quality, Procedural Lapses At Alembic Pharma’s Gujarat Facility

The U.S. drug regulator has flagged quality and procedural lapses at Alembic Pharmaceuticals Ltd.'s injectable facility in Vadodara, Gujarat.

“The U.S. Food and Drug Administration has conducted an inspection at Alembic Pharmaceuticals' injectable facility located at Karkhadi from Aug. 18^-30. The U.S. FDA issued a Form 483 with two observations,” the company has said in a Sept. 1 exchange filing.

A Form 483 is issued when investigators have observed any condition that in their judgment may constitute violation of the Food Drug and Cosmetic Act and related acts.

None of the observations were related to data integrity and were addressable, the filing stated. “The company is preparing the response to the observations, which will be submitted to the U.S. FDA within stipulated period.”

BQ Prime has obtained a copy of the observations from the FDA.

These are:

1. Aseptic processing areas are deficient regarding air supply that is filtered through high-efficiency particulate air filters under positive pressure. Specifically, the airflow visualisation studies do not provide adequate visualisation of the airflow patterns at critical areas for aseptic drug product filling.

2. Four out of six deviation investigations reviewed did not mention appropriate actions to be taken to prevent reoccurrence. Investigations related to cracked HEPA (high efficiency particulate air) filter, temperature excursions (deviation from set temperature range), pump failure during filling of solution and visible product traces on the inside of the holding vessel during cleaning validation study, were concluded without suggesting preventive action.

The drugmaker has yet to respond to BQ Prime's emailed queries on the implications of the observations, revenue contribution from the facility and their impact on future approvals and launches. It's also yet to comment on the steps being taken to address these issues and the expected timelines for resolution.

Shares of Alembic Pharma have fallen 4.37% since Sept. 1, in line with the Nifty 50. Of the 18 analysts tracking the company, two maintain a ‘buy', six suggest a ‘hold' and 10 recommend a ‘sell', according to Bloomberg data. The average of the 12-month target price implies a 10.8% upside.