USFDA issues warning letter to Jubilant Life over CGMP norms

The US health regulator has found significant violations of good manufacturing norms at the Indian drug company Jubilant Life Sciences' Washington facility for finished pharmaceuticals.

The manufacturing facilities, Jubilant HollisterStier, LLC (JHS) located at Spokane, Washington state, was inspected between April 15 and May 10, 2013, the US Food and Drug Administration (USFDA) said in a warning letter to company's CEO Marcelo A Morales.

Investigators from USFDA found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals, it added.

"The violations cause your 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," USFDA said.

One of the specific violations which the investigators found was failure to establish written procedures, that are designed to prevent microbiological contamination of drug products purporting to be sterile, and that include validation of all aseptic and sterilisation processes, it added.

The other violation was failure to adequately document all work orders associated with the April 2013 shutdown and include appropriate quality unit oversight.

"Your firm failed to assure an adequate system for cleaning and disinfecting aseptic processing areas and equipment," USFDA said.

"The company should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action without further notice including, without limitation, seizure and injunction," it added.

"Within fifteen working days of receipt of this 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," USFDA said.

According to the company's website, the Spokane plant contract manufactures sterile injectables and allergenic extract.

Shares of Jubilant Life Sciences today ended at Rs 116.50 per scrip on BSE, down 2.51% from its previous close.