Bags of shredded docs: Indian drugmaker Lupin handed a Form 483 by FDA inspectors
The generics manufacturer Lupin has been given another Form 483 from the FDA this year.
US regulators inspected Lupin’s pharmaceutical manufacturing site in the town of Mandideep, India from Nov. 14 through Nov. 23, with the 14-page report marking 16 observations.
The inspection report stated that the site did not have the appropriate controls over its computer systems to ensure that changes in “master production” or records are only done by authorized personnel, along with written procedures not being established to conduct annual reviews of records associated with drug batches.
Inspectors also noted that the site had 68 bags filled with “shredded documents” at the site’s trash collection area. But the site didn’t have an adequately described process for which GMP documents should be shredded.
The “routine calibration” of automatic and mechanical equipment was also not done. Procedures for the quality control unit were not in writing and not being fully followed.
For observations related to active pharmaceutical ingredients (APIs), inspectors found that “critical process parameters” in the manufacturing of ingredients were not being continuously monitored. Computer systems did not have “sufficient controls” to prevent changes to data or unauthorized access. A number of other specific observations related to engineering practices and other procedures.
Endpoints News reached out to Lupin for comment on the inspection and other details but did not receive a response by press time.
This is not the first time this year that Lupin has been under the microscope from the FDA. An inspection from Oct.3 to Oct. 14 of this year, at Lupin’s biosimilar manufacturing facility in Pune, India, had 10 observations noted. Some of the items noted by FDA inspectors included not appropriately evaluating for a microbial contamination and protective apparel that was not always being worn.
Lupin has also been handed down a warning letter this year as well. The letter received in October noted that it had suspended the production of drugs for the US market and must notify the FDA if it wants to restart making drugs for the US.