Tuesday, June 18, 2024

Regulatory Actions: FDA Issues Second Notice to Laurus Synthesis for Quality Control Failures

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The U.S. Food and Drug Administration (FDA), after issuing a regulatory Form 483 to India’s Laurus Synthesis in January, has escalated its regulatory actions with an “untitled letter” that highlights continuing issues with the drugmaker’s compliance, particularly concerning quality control processes and equipment cleaning practices. An “untitled letter” from the FDA points out regulatory violations that do not meet the threshold for a “warning letter,” but are still significant enough to warrant attention.

In this latest correspondence, the FDA criticized Laurus Synthesis’ quality control unit for failing to adequately investigate and resolve critical deviations identified during a December inspection at its Anakapalli manufacturing facility in Andhra Pradesh, India. This inspection had previously led to the issuance of a regulatory Form 483.

The untitled letter specifically highlighted that Laurus’ quality unit did not thoroughly investigate an out-of-specification (OOS) result related to its water system. Instead of probing the root cause of the OOS result, Laurus simply resampled the water system, received a passing result, and did not take further action to investigate the original OOS result or implement improvements to prevent future contamination.

FDA Raises Regulatory Concerns Over Laurus’ Equipment Cleaning and Quality Control Practices

The FDA noted Laurus’ failure to properly clean equipment and utensils, which could potentially lead to contamination of the active pharmaceutical ingredients (APIs) manufactured at the site. Investigators observed “apparent dirt and dark residue” on a piece of equipment that had been listed as “in a clean state” in the company’s preventative maintenance report.

As a corrective regulatory measure, the FDA recommended that Laurus hire an independent manufacturing consultant to perform a comprehensive audit of the company’s entire operation. This recommendation underscores the FDA’s concerns about the overall adequacy of Laurus’ quality management systems from a regulatory standpoint.

The issues outlined in the untitled letter echo problems previously identified in the FDA’s regulatory Form 483. The Form 483 cited Laurus for not adequately investigating unexpected occurrences, having insufficient sampling plans for intermediates, and failing to maintain equipment in a manner that prevents contamination.


FDA Emphasizes Regulatory Compliance as Laurus Faces Issues with Batch Production Records

The Form 483 highlighted that Laurus kept incomplete records related to batch production and controls, a critical component of pharmaceutical manufacturing compliance. Dr. Richard Hatchett, CEO of CEPI, emphasized the urgency for local vaccine production in Africa to avoid the inequities witnessed during the COVID-19 pandemic, noting that Africa still imports 99% of all vaccines it needs, resulting in significant delays for life-saving doses.

The need for stringent regulatory quality control in pharmaceutical manufacturing cannot be overstated, particularly as global efforts are made to ensure equitable access to vaccines and medications. The FDA’s regulatory actions against Laurus Synthesis reflect the ongoing challenges in maintaining high standards in the production of pharmaceuticals, especially in markets that are critical to global health initiatives.

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Resource: Food and Drug Administration, May 16, 2024

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