India’s leading drug maker Sun Pharmaceutical Industries has received four observations for its Halol facility in Gujarat following an inspection by the US Food and Drug Administration (USFDA).
The USFDA has flagged that the facility is not following procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile.
The regulator has also observed that lab control mechanisms were not documented, design plans not adequately established, and the processes whose results could not be fully verified by subsequent inspection were not adequately validated.
Sun Pharma has said it will respond to the observations soon. “Sun Pharma intends to implement promptly any corrective actions and improvements that may be necessary and remains committed to following the highest levels of quality and 24x7 cGMP compliance at all its manufacturing sites globally,” a spokesperson said. Pharma companies
are provided with a window of 15 days to respond to such observations. Based on the responses, Sun Pharma's Halol facility may bag either of the statuses such as no action indicated, voluntary action indicated or official action indicated.
The inspection at Halol began on June 3 and went on for at least a week, according to industry sources. Though a routine inspection, the development had caused flutters among investors and analysts given Halol’s significance as Sun Pharma’s key unit that supplies products to the US. The unit contributes as much as 10-15 per cent to the company’s US sales, despite a challenging regulatory history.
Analysts believe the inspection was probably part of a pre-product approval. “It seems some products are up for approval. However, while it was a longer inspection, it has resulted in mostly routine observations which explain why the stock is up," an analyst said on the condition of anonymity.
Last year, the facility had seen two inspections with the first resulting in a status upgrade from OAI to VAI, which meant the drug major would undertake necessary remediation and communicate the same to USFDA. Later in August, following its responses to six observations, the Halol facility had received an NAI status from the regulator, allowing Sun Pharma to continue manufacturing.