On the heels of an FDA citation and export halt at Sun Pharma’s Mohali, India, manufacturing operations, the U.S. drug regulator is making clear that its demands for corrective actions are nonnegotiable.
The FDA has ordered Sun to enlist a current good manufacturing practices (CGMP) expert as the Indian drugmaker works to right the ship at its Mohali site, where the company last summer received a six-observation Form 483 tied to inadequate testing and on-site record-keeping.
The company must fulfill the FDA’s demands before it can release any finished drug product batches bound for the U.S., the regulator said in compliance documents made public last week.
Late last month, Sun pushed the pause button on manufacturing of U.S.-bound drugs at Mohali after the FDA changed the classification of an August 2022 inspection from “Official Action Indicated” to “Consent Decree Correspondence/Non-Compliance.” The latter classification is the more serious of the two.
Aside from generally ensuring Sun’s manufacturing work is aboveboard, the CGMP consultant must carry out batch certifications for drugs manufactured at the plant.
Going forward, if at any point Sun’s drug products miss the mark on identity, strength, quality or purity, the CGMP expert must furnish the FDA with a written explanation for the batch failure within 30 days, the agency said.
“No drug from such batch may be introduced into the United States,” the FDA said in its compliance document.
This process will continue for at least a year, at which point the consultant would take on the role of a “CGMP Auditor,” the FDA said. Those duties will continue “until FDA is satisfied that the Mohali facility is operating in compliance with CGMP.”
Meanwhile, Sun isn’t the only Indian drugmaker to find itself in the FDA’s crosshairs lately. Ipca Laboratories’ site in Silvassa, India, has been slapped with three observations following an FDA inspection that ran from April 18 to April 26 of this year.
Ipca failed to properly investigate unexplained discrepancies and batch failures, the FDA said in a recent Form 483 filing. Further, the company has not codified its quality control unit’s duties in writing, nor are those responsibilities and procedures “fully followed,” the agency said.
In one instance, the FDA noted an Ipca logbook that had “consistent non-readable printouts” signed by microbiologists, a microbiology supervisor and the company’s quality unit. “No action was taken to rectify the problem,” FDA said.