Sun Pharma again faces FDA heat on Halol plant
US drug regulator makes six observations related to deficient procedures
New Delhi: 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 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. However, on Friday, the FDA issued six observations for inspections conducted during 27-31 August.
The FDA 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. It also said that the facility did not have procedures in place that require “across batch trending of critical alarms raised during production activities”.
Shares of Sun Pharmaceutical Industries Ltd fell 1.84% from its previous close to ₹664.20 at the Bombay Stock Exchange on Friday.
A Sun Pharma spokesperson said the company is committed to addressing these issues promptly.
“The USFDA conducted a Pre-Approval Inspection of Sun Pharma’s Halol facility from 27 August to 31 August. At the conclusion of the inspection, the agency issued a Form 483 with six observations. The company will submit its response to the FDA within 15 business days,” the spokesperson said.
Interestingly, the US arm of Sun Pharma on 2 August had also recalled more than 2,500 bottles of Metformin hydrochloride extended release tablets from Arizona because of the presence of a foreign substance in one lot. These tablets were manufactured at its Halol plant.
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