USFDA Raises Compliance Concerns at Hetero Labs' Nakkapalli Facility

According to the inspection report, the USFDA observed that finished APIs intended for export to the United States were released to an off-site warehouse without proper documentation. It also flagged the use of an unregistered testing laboratory located outside the official premises. Additionally, the regulator noted failures to record out-of-specification (OOS) results from the unregistered lab, along with other procedural shortcomings — all pointing to serious deficiencies in the company’s adherence to regulatory and manufacturing standards.

Hetero Labs is a major player in the API segment and India’s second-largest manufacturer in the antiretroviral market. Experts suggest that any escalation in regulatory action or delay in compliance could disrupt supplies from the Nakkapalli site, creating potential opportunities for competitors such as Laurus Labs and Aurobindo Pharma to capture market share.

CNBC-TV18 reports that the market is keenly observing Hetero Labs’ response to the Form 483 and the subsequent actions by the USFDA.

To elaborate, Form 483, officially titled “Notice of Inspectional Observations”, is issued by the U.S. Food and Drug Administration (USFDA) at the conclusion of an inspection of a pharmaceutical, biotech, or medical device facility. It lists observations of potential regulatory violations related to Good Manufacturing Practices (GMP), quality systems, or compliance with FDA regulations. While it is not a final agency action, a Form 483 signals areas that require correction, and companies are expected to respond promptly with corrective and preventive actions (CAPA). Failure to adequately address Form 483 observations can lead to warning letters, import alerts, or legal enforcement actions.