Sun Pharmaceutical Industries Ltd (Sun Pharma) has confirmed that the US food and drug administration (US FDA) has classified its Halol facility as 'official action indicated' (OAI), following an inspection conducted between 2nd June and 13 June 2025. The designation indicates that the plant is not fully compliant with current good manufacturing practices (CGMP), raising concerns about the sterility and quality of medicines manufactured there.
The Halol plant, a key unit for the company’s US generics business, remains under an import alert. This status prevents shipments from the facility from entering the US, except for certain medicines exempted due to drug shortages.
In a regulatory filing, Sun Pharma says, "The Halol facility is under import alert, resulting in the refusal of shipments from the facility into the US, barring certain exemptions due to drug shortage, until the facility becomes fully compliant with FDA and CGMP standards. Sun Pharma remains committed to working with the FDA and maintaining CGMP standards at all of its facilities to provide high-quality medicines to patients globally."
FDA’s Critical Observations from June 2025
- Observation 1
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established and followed. Examples of poor aseptic behaviour and inadequate environmental monitoring are repeat observations from the December 2022 warning letter.
- Observation 2
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include adequate validation of the aseptic process. Inadequate media fills is a repeat observation from the December 2022 warning letter.
- Observation 3
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has already been distributed.
- Observation 4
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design to facilitate operations for its intended use.
- Observation 5
Your firm failed to establish adequate written procedures for production and process controls designed to assure that the drug products have the identity, strength, purity, and quality that they are purported or represented to possess.
- Observation 6
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to assure that drug products confirm to appropriate standards of identity, strength, quality and purity.
- Observation 7
Equipment and utensils are not maintained at appropriate intervals to prevent malfunctions and contamination that would alter the safety, identity, strength, quality or purity of the dmg product.
- Observation 8
Batch production and control records do not include complete information relating to the production and control of each batch.
The FDA concluded that these deficiencies posed serious risks to drug safety and patient health.
Citing internal correspondence, the report says Sun Pharma executives repeatedly pledged facility upgrades, new staffing, and stricter quality protocols. "Yet, for eight years, FDA inspectors kept finding dirty equipment, impurities in injectable medicines, and inadequate safeguards against contamination."
ProPublica noted that as early as 2015, FDA had declared the factory’s products 'adulterated', meaning they were manufactured in a way that could compromise their strength, quality, or purity. However, despite mounting evidence of lapses, the agency allowed the continued flow of generic drugs from Halol to the US market, citing demand for affordable medicines.
In June 2025, inspectors found practically identical deficiencies to those flagged more than a decade earlier, including workers handling sterile drugs without clean gloves.
While FDA has kept the import ban in place, it has permitted Sun Pharma to ship certain drugs deemed essential to address shortages in the US market.
The repeated findings have not only cast a shadow over Sun Pharma’s compliance record but also reignited concerns about regulatory oversight. As the world’s largest generic drug maker by market value, Sun Pharma plays a pivotal role in supplying affordable medicines globally.
The company says it will continue engaging with FDA to address the deficiencies and restore full compliance at Halol. Meanwhile, further scrutiny is expected as the regulator weighs enforcement action.
