FDA warns RPG Life Sciences

In a sign of intensifying trouble for the domestic drug manufacturing industry globally, yet another pharmaceutical company has come under the scanner of the US drug regulator. The US Food and Drugs Administration (FDA) recently issued a warning letter to Mumbai-based RPG Life Sciences for violations of good manufacturing practices at two of its facilities. The FDA might also withhold new approvals for the company until it satisfies the regulator with corrective measures.

"We highly recommend that you hire a third party auditor, with experience in detecting data integrity problems, to assist you with this evaluation and assist with your overall compliance with CGMP (current good manufacturing practices). It's your responsibility to ensure that data generated during operations are accurate and that the results reported are a true representation of the quality of your APIs (active pharmaceutical ingredients) and drug products," the regulator said in the warning letter, dated May 28, addressed to RPG Life Sciences managing director Ajit Singh Chouhan.

The regulator inspected the company's manufacturing facilities in Ankleshwar (Gujarat) during November last year and that in Navi Mumbai (Maharashtra) in January this year and found significant violations of its CGMP norms for finished pharmaceuticals and API manufacturing at respective units, the letter said.

"These violations cause your APIs and drug products to be adulterated within the meaning of Section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. 351(a)(2)(B), in that the methods used in, or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with, CGMP," the FDA said in its letter, detailing the violations identified by its investigators during inspection of both the facilities.

According to the letter, the FDA had also issued a Form 483 to the company with its observations following the inspections. However, the company's response to the Form 483 failed to satisfy the regulator and hence, invited a warning letter.

"Until all corrections have been completed and FDA has confirmed corrections of the violations and your firm's compliance with CGMP, FDA may withhold approval of any new applications or supplements listing your firm as a drug product manufacturer," the letter said, adding FDA may even bar supplies of drugs to the US from these facilities if the company fails to correct violations.

The FDA has asked RPG Life Sciences to respond to its letter within 15 working days of receipt of the warning letter. "Please notify this office in writing of the specific steps that you have taken to correct and prevent the recurrence of violations, and provide copies of supporting documentation. If you cannot complete corrective actions within 15 working days, state the reason for the delay and the date by which you will have completed the corrections," it said.

INSPECTED
|RPG Life Sciences warned for violations of good manufacturing practices at two of its facilities
|FDA might also withhold new approvals for the company until it satisfies the regulator with corrective measures

|Found significant violations during inspection of the company's manufacturing facilities in Ankleshwar and Navi Mumbai