Sun Pharma again faces FDA heat on Halol plant in Gujarat

NEWDELHI: Drug major Sun Pharmaceutical Industries Ltd has come under the US Food and Drug Administration (FDA) scanner once again with the regulator issuing six observations on Friday related to deficient procedures at its Halol manufacturing facility—just two months after the unit was cleared for making cancer drugs.

The facility in Gujarat received its first approval in four years from the US FDA for a product used to treat cancer only in June. The Halol plant had been under FDA scanner since September 2014. In December 2015, the plant was served a warning letter, following an inspection that revealed alleged quality issues. Since then, no new products manufactured at the facility had been approved. However, in June this year, a resolution of the issue paved the way for Sun Pharma to resume selling to the US market from this facility, which accounts for 35-40% of the company’s revenue.

The facility came under the lens once again, with the USFDA on Friday issuing six observations for inspections conducted during August 27-31. The FDA

KEY OBSERVATIONS BY THE FDA

Lack of appropriate lab controls and test procedures to assure products conform to standards of quality, purity

Procedures designed No written procedures for production and to prevent process controls designed to assure that the objectionable products have the identity, strength, quality microorganisms in and purity they purport. drug products not Written procedures not being followed for being followed cleaning, maintenance of equipment

alleged lack of appropriate laboratory controls and appropriate test procedures designed to assure that drug products conform to standards of quality and purity. Further, the FDA said procedures designed to prevent objectionable microorganisms in drug products were not being followed.

It also said that there were no written procedures “for production and process controls designed to assure that the drug

products have the identity, strength, quality, and purity they purport”. The FDA observed that cleaning and maintenance of equipment did not see any written procedures being followed. Likewise it said the facility did not have procedures in place which require “across batch trending of critical alarms raised during production activities”.

A firm spokesperson said the firm is committed to addressing these issues promptly.