The U.S. Food and Drug Administration flagged two procedural lapses related to laboratory controls at Lupin Ltd.'s oral solid dosage facility in Nagpur, Maharashtra.
“U.S. FDA inspected Lupin's Nagpur oral solid dosage facility from July 3 to July 11," the company said in a July 12 exchange filing. "The inspection closed with issuance of a Form-483 with two observations.”
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.
“We are confident of addressing the observations raised, and will work with the U.S. FDA to resolve them at the earliest,” the company said.
BQ Prime has obtained a copy of the observations from the administrator. These are the observations that were made:
Laboratory records do not include a complete record of all data obtained during testing. Two instances were highlighted. FDA observed that the controls were deficient for securing electronic laboratory data, as in security controls over data were removed without justification. Also, several instances were observed where randomly selected sequences for analytical record review were aborted. This concern would impact commercially distributed batches, where out-of-specification or any other discrepancy is observed but the analyst does not allow a complete assessment, by aborting the sequence.
Quality control laboratory does not have a complete record of samples received for testing. They do not include description of sample received, the quantity of sample and date the sample was received for testing.
Queries sent to Lupin via email have note received a response till now. The company is also yet to comment on the steps being taken to address these issues and the expected timelines for resolution.
Shares of Lupin closed 1.43% higher on Thursday, compared to a 0.71% rise in the benchmark Sensex.
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