Sun Pharma Temporarily Pauses Shipments from Mohali Following FDA’s Mandate for Corrective Actions

Headquartered in Mumbai, India, Sun Pharma has announced that the company will put a temporary halt to the release and shipment of batches of finished product to the US market from a facility in Mohali, Punjab. The decision is in line with corrective steps according to the guidance from the U.S. Food and Drug Administration (FDA).

As the world’s fourth largest (India’s largest) specialty generic pharmaceutical company with the U.S. as its biggest market, Sun Pharma has said in its update that it received a letter from the FDA with the title “Consent Decree Correspondence/Non-Compliance Letter”. According to this letter, the FDA directed the Indian drugmaker to “take corrective actions at the Mohali facility before releasing further final product batches into the U.S.”  

Related article: FDA Announces Two Product Recalls Over Concerns of Particulates and Impurities 

“Official Action Indicated (OAI)” Classification Following FDA’s Inspection

Sun Pharma’s Mohali facility appeared on the FDA’s radar screen following an inspection from August 3 to August 12, 2022. The regulatory agency issued a Form 483 (Notice of Inspectional Observations) to the drugmaker, with 6 observations which may constitute violations of the Food, Drug and Cosmetic Act and related laws and regulations. Examples of these regulatory issues include a failure to thoroughly review unexplained discrepancies, deficiency in laboratory testing records, and negligence to incorporate the establishment of scientifically sound and appropriate test procedures to assure the quality and purity of drug products.

The FDA classified this inspection as “Official Action Indicated (OAI)”, meaning that the agency had found objectionable conditions in the Mohali facility which required regulatory and/or administrative actions. Some possible actions include a prompt re-inspection, a delayed approval, a warning letter, an injunction, or even prosecution. In general, plants that have received OAI status must undergo a re-inspection by FDA officials to ensure compliance.

The largest drugmaker in India is taking a series of corrective steps in accordance with FDA’s requirements. According to the company’s update, “these actions include, among others, retaining an independent CGMP (Current Good Manufacturing Practice) expert to conduct batch certifications of drugs manufactured at the Mohali facility.”

The company has also stated that there will be a temporary pause in the release of batches from Mohali until the FDA-mandated measures are implemented, and that U.S. shipments from Mohali will resume once these measures are in place.

Another Regulatory Blow to India’s Largest Drugmaker

Shares of Sun Pharma fell by about 3% after the company temporarily suspended production at its Mohali facility to comply with FDA regulations. 

In fact, the above-mentioned non-compliance letter is not Sun Pharma’s only regulatory setback over the past year. In an FDA inspection at the company’s manufacturing plant in Halol, Gujarat from April 26 to May 9, 2022, the agency identified significant violations of CGMP regulations for finished pharmaceuticals, including poor aseptic practices for preventing microbiological contamination, inadequate cleanroom design and environmental monitoring and failure to keep manufacturing equipment clean. 

These violations prompted the FDA to place the firm on import alert on 7 December, refusing products manufactured at the Halol facility from entering the U.S. until the facility becomes compliant with CGMP standards. Furthermore, the agency later issued a strongly-worded warning letter to Sun Pharma, stating that “Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your drug products are adulterated.”

Author

Richard Chau