Dr Reddy’s Laboratories has announced that its Active Pharmaceutical Ingredient (API) manufacturing facility in Mirfield, West Yorkshire, United Kingdom, has come under scrutiny from the United States Food and Drug Administration (FDA). Following an inspection conducted between 1 and 5 September, the site was issued a Form 483 with seven observations.

The Form 483 is issued when FDA inspectors believe that conditions observed may constitute potential violations of the Food, Drug, and Cosmetic Act. While it does not represent a final determination, it highlights areas that require corrective action. Dr Reddy’s has confirmed that it will respond to the FDA within the stipulated timeframe and take all necessary measures to address the concerns.

The Mirfield site plays a key role in producing active pharmaceutical ingredients that are supplied globally. Observations of this nature are not uncommon in the pharmaceutical industry, but they often attract close attention from regulators, investors, and stakeholders, given their potential impact on compliance and future approvals.

The company emphasised its commitment to maintaining the highest quality and compliance standards across all facilities. It added that it remains focused on resolving the issues promptly to ensure uninterrupted operations and adherence to regulatory expectations.