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The US health watchdog FDA in its observation has found major anomalies – including systemic data manipulation and manufacturing norm violations – at the three plants of Ipca Laboratories.
According to the warning letter sent by the USFDA over the three plants, its inspectors observed systemic data manipulation and other current good manufacturing practices violations and deviations at the company's three facilities.
Elaborating on the drug firm's Ratlam (Madhya Pradesh) facility, the USFDA said: "We observed systemic data manipulation across your facility, including actions taken by multiple analysts, on multiple pieces of testing equipment, and for multiple drugs."
During the inspection of the microbiology laboratory, "our investigators observed multiple examples of your firm's practice of back-dating and falsifying laboratory data," the regulator said.
Besides, the FDA investigators discovered a lack of basic laboratory controls to prevent changes to the company's electronically stored data.
"Your firm relied on incomplete records to evaluate the quality of your drugs and to determine whether your drugs conformed with established specifications and standards," USFDA noted.
Further, the company failed to adequately investigate and resolve critical deviations.
"Our inspection documented that your firm's quality unit was aware of the lack of controls in your computerised systems to prevent the manipulation and deletion of quality-related data," the USFDA said.
"Your site's senior management failed to take sufficient corrective action and prevent the recurrence of these problems," it added.
Commenting on the company's Pithampur (Madhya Pradesh) facility, the USFDA said the company failed to ensure that laboratory records include complete data derived from all tests necessary to assure compliance with established specifications and standards.
On the third plant in Piparia (Silvassa), the USFDA said: "During our inspection, we documented that your quality control laboratory was conducting trial injections of samples but failed to report all of the data generated."
"Your laboratory controls failed to establish scientifically sound test procedures to assure that your drug products conform to appropriate standards of identity, strength, quality and purity," the USFDA added.
Until the company completes all corrections, the US health regulator may withhold approval of company's any new applications or supplements, the USFDA said.
"Failure to correct these violations may also result in FDA refusing admission into the United States of articles manufactured at the three facilities," it added.
