Indian drug maker Cipla Ltd. has been served 483 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 noted that the quality control unit lacked authority to review production records to assure that no errors have occurred and investigate errors that occurred.
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.
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