Indian drug maker Cipla has been served nine observations by the U.S. Food and Drug Administration (FDA) for its Indore-based manufacturing unit as part of an inspection that was conducted during July and August this year. The observations is a summary note of issues noticed by the FDA officials and needs corrections.
Cipla remains amongst the few large domestic companies that has so far not faced tough regulatory actions from the US FDA.
While the company declined to share details of the US Food and Drug Administration (US FDA) observations, brokers said as many as nine issues have been raised by the regulator under 'Form 483' regarding manufacturing practices in the plant.
A company is required to respond to the US FDA in writing with its corrective action plan and then implement that corrective action plan expeditiously.
More specifically, they said in the note that an out-of-specification for levalbuterol inhalation solution resulted in a voluntary recall of one batch from the US market in May 215. "However the investigation did not extend into other strengths of the product to determine the product's quality, safety and stability," the observation which is part of the Form 483 said.
In another observation, a failure related to a leakage was documented 35 times but no investigation was initiated to identify problems that may potentially affect the product safety and quality.
The observation further stated that a failure related to a leakage was documented 35 times and no investigations were taken place in the matter, which might have affected the product safety and quality.
Cipla's Indore unit has also been faulted for facility and equipment systems. The officials observed that aseptic processing areas were deficient regarding the system for monitoring environmental conditions.
The US FDA staff stated the sterile filling lines were opened quite often in order to complete manual interventions during product filling. .