USFDA issues warning letter to RPG Life Sciences

Regulator warned that the failure on the part of the company's management to correct the violations may result in a ban

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US Food and Drug Administration (USFDA) has issued a warning letter to RPG Life Sciences for violation of current good manufacturing practice (CGMP) norms at its two plants at Ankleshwar and Mumbai.

"During our November 20, 2012 through November 24, 2012 inspection of your pharmaceutical manufacturing facility, MS-Ankleshwar, investigator(s) from the FDA identified significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals," the health regulator said in a letter posted on its website.

Likewise, during an inspection of the pharmaceutical manufacturing facility, at Navi Mumbai, investigators from the FDA identified significant deviations from CGMP for the manufacture of active pharmaceutical ingredients (APIs), it added.

"These violations cause your APIs and drug products to be adulterated ...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," USFDA said.

When contacted, a company spokesperson declined to comment.

The US health regulator said that it has conducted a detailed review of RPG Life Sciences' responses dated December 11, 2012 and February 19, 2013 and "note that they lack sufficient corrective actions".

"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," USFDA said.

USFDA further warned that the failure on the part of the company's management to correct the violations may result in banning of import of drugs manufactured at the company's facilities at Ankleshwar and Navi Mumbai, into the United States.