The U.S. drug regulator has flagged procedural lapses at Aurobindo Pharma Ltd.’s Srikakulam, Andhra Pradesh, facility.
The U.S. Food and Drug Administration inspected Aurobindo’s bulk drug manufacturing facility, Unit XI, situated at Pydibhimavaram from July 25 to Aug. 2, the company had said in its Aug. 2 exchange filing. “At the end of the inspection, we have been issued a Form 483 with three observations and none of these observations are related to data integrity.”
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.
The company, the filing said, is preparing the response to the observations, which will be submitted to U.S. FDA within the stipulated timeline. On May 17, 2019, the unit was classified as “official action initiated” and was subsequently issued a warning letter on June 20, 2019. The company had responded to the warning letter and carried out the committed corrections, Aurobindo pharma said in its filing.
BQ Prime has obtained a copy of the recent observations from the FDA.
Procedures for cleaning and maintenance of equipment are deficient. Re-cleaning operations for equipment initiated by the company were not completed for over 20 days and visible white powder and rust was observed on manufacturing equipment.
Failure to thoroughly investigate unexplained discrepancy in a batch. Complaints indicating instrument failure, communication failure and sequence stopping due to errors for equipment used to perform stability testing for API batches manufactured for the U.S. were not adequately investigated. Evaluation of market complaints about black particles in products was not done.
Procedures applicable to the quality control unit are not fully followed. Laboratory data not recorded as per good manufacturing practices and standard operating procedures and time lag in initiation of deviations observed.
The drugmaker has yet to respond to BQ Prime’s emailed queries on the implications of the observations, the revenue contribution of the facility, and impact on future approvals and launches.
The company is also yet to comment on the steps being taken to address these issues and the expected timelines.