Cipla gets FDA's nine observations and issues noticed memo for Indore unit

MUMBAI: Indian drug maker Cipla has been served nine observations by the US 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.

As part of its observations, FDA investigators Ademola Daramola and Nebil Oumer noted that the quality control unit lacked authority to review production records to assure that no errors have occurred and investigate errors that occurred.

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 FDA officials faulted Cipla's Indore unit for facility and equipment systems noting that the aseptic processing areas are deficient regarding the system for monitoring environmental conditions.

On one of the observations related to quality parameters, the FDA staff noted that the sterile filling lines were frequently opened in order to complete manual interventions during product filling. "In the packaging hall, sterile product vials exiting the filling line were handled with ungloved and unsanitized hands by packaging line employees" the note further said.