Aurobindo Receives FDA Warning Letter for API Mfg Violations

The US Food and Drug Administration (FDA) has issued a Warning Letter to Aurobindo Pharma for its drug-manufacturing facility in Srikakulam District, Andhra Pradesh, India, citing deviations from current good manufacturing practice (cGMP) for active pharmaceutical ingredients (APIs). The agency conducted an inspection of the facility from February 4 to February 9, 2019.

In the Warning Letter, the FDA cited the company for not adequately investigating the root cause of impurities in certain APIs by not evaluating the key starting materials, other raw materials, and solvents in relation to such impurities.

Separately, the FDA further noted the company’s quality unit failed to report to the FDA the non-carcinogenic impurities found in specific APIs that exceeded thresholds in residual-solvents testing.

The FDA also cited the company for inadequate investigation into poor equipment maintenance as the agency observed what appeared to be rust on manufacturing equipment. The FDA said the company’s investigation into this did not sufficiently extend to other equipment that may also not be properly maintained.

The FDA requested several action items for the company, including identifying corrective actions to ensure adequate quality oversight of operations for contract manufacturers performing functions that could affect drug quality, including any revised qualification and evaluation procedures. It also requested risk assessments for all APIs and intermediates manufactured at the company’s facility for the potential presence of mutagenic impurities. Additionally, the FDA requested that the company conduct a thorough review of all batches of API made at Aurobindo that shows unknown impurities above the reporting thresholds and to provide a thorough, independent assessment of the company’s overall system for investigating unknown peaks, deviations, discrepancies, out-of-specification (OOS) results, complaints, and other failures.

The agency also requested that the company provide a comprehensive assessment of the state of maintenance of all equipment that can be used in the manufacture of drugs for the US and to provide a corrective and preventive action plan that includes a full review of all equipment contact surfaces to determine if they are reactive/additive to the company’s drugs and whether contact surfaces are suitable for its intended uses.

Source: FDA

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