U.S. FDA Identifies Lapses at Biocon's Insulin Facility in Malaysia

U.S. FDA Identifies Lapses at Biocon's Insulin Facility in Malaysia

www. headlinestoday.news - In a recent development, the U.S. Food and Drug Administration (FDA) has highlighted eight instances of non-compliance at Biocon Ltd.'s insulin manufacturing facility located in Malaysia. These observations pertain to various aspects of the facility's operations, including biologic drug substances, drug product units, quality control laboratories, and delivery device units.

The FDA's inspections, conducted between July 10 and July 20, 2023, under the current good manufacturing practices (cGMP), led to the issuance of a Form 483. Out of the six observations made, four were related to drug substances, drug product units, and quality control laboratories, while the remaining two focused on the delivery device unit.

Notably, the flagged issues primarily revolve around the need to enhance operational procedures and strengthen training programs within the facility. Despite the observations, there were no findings of data integrity breaches or systemic non-compliance during the inspections.

Of particular concern, one observation was a repeat of a previous finding. The repeated observation emphasized the need for established procedures to prevent microbiological contamination of drug products that are intended to be sterile.

Another observation pointed out the failure to conduct thorough reviews of batch failures or components not meeting specifications, irrespective of whether the batch had been distributed. Additionally, there were instances where assigned root causes for laboratory out-of-spec results lacked scientific justification.

Further observations revealed gaps in corrective and preventive action activities and documentation related to devices. Notably, the risk management report lacked a comprehensive discussion on controlling the injection force of the finished product.

Biocon's spokesperson responded to the FDA's findings, stating, "We remain committed to global standards of quality and compliance and look at this as an opportunity to further strengthen our processes." The company's generic Insulin Aspart, a new product awaiting approval, was unaffected by the inspections, according to the spokesperson.

Biocon had previously submitted a comprehensive Corrective and Preventive Action Plan (CAPA) to the FDA following a similar inspection of the Malaysia facility. This CAPA plan was accepted by the agency. However, the timeline for the approval of Insulin Aspart in the U.S. remains uncertain.

The company's Insulin Aspart has already gained approval in various global markets, including EMA, and was launched in Canada in FY23. The company hopes to expand its Insulins portfolio for diabetes patients in the U.S. upon receiving FDA approval for the biosimilar Aspart.

In response to these developments, Biocon's shares experienced a marginal decline of 0.31%, trading at Rs 255.65 per share at 3 p.m. on Monday. This decline contrasted with a 0.23% rise in the benchmark Sensex during the same period.