Aurobindo’s Ralieigh NC Plant Hit With 483

Aurobindo’s Ralieigh NC Plant Hit With 483

April 22nd, 2025 // 12:08 pm @ jmpickett

FDA conducted a cGMP inspection of Aurobindo Pharma Limited’s facility in Raleigh, NC from March 24 to April 10, 2025. Aurobindo’s facility produces inhalers and dermatology products, including topical creams and ointments. The company received an 11-item 483. Further details are noted below.

FDA Form 483 Details

• Inspection Dates: March 24, 2025 – April 10, 2025
• Number of Observations: 11
• Nature of Observations: Aurobindo Pharma characterized the observations as procedural in nature, indicating they likely involve deficiencies in standard operating procedures (SOPs), documentation, or compliance with Current Good Manufacturing Practices (CGMP) rather than critical issues like data integrity or product contamination. The exact details of the observations have not been publicly disclosed, as the FDA has not yet published the Form 483 document.
• Facility Focus: The Raleigh plant is designed for manufacturing inhalers and dermatology products, which are sensitive to quality control due to their delivery mechanisms and direct patient application.

Company Response

• Commitment to Corrective Actions: Aurobindo Pharma stated it will submit a comprehensive response to the FDA within the stipulated timeline (typically 15 business days). The response will include Corrective and Preventive Actions (CAPA) to address each observation.
• Business Impact: The company asserted that the observations are not expected to have a material impact on current business operations or existing supplies from the Raleigh facility. This suggests that the issues are manageable and unlikely to disrupt production or lead to product recalls at this stage.
• Regulatory Compliance: Aurobindo emphasized its commitment to maintaining the highest standards of quality and compliance across its operations.

Context and Historical Perspective

• Previous FDA Interactions at Raleigh:
  • In August 2022, the FDA conducted a pre-approval inspection (PAI) and GMP inspection at the same Raleigh facility, issuing a Form 483 with one observation, also described as procedural. The facility later received an Establishment Inspection Report (EIR) with a Voluntary Action Indicated (VAI) classification, meaning no significant regulatory action was deemed necessary at the time.
• Aurobindo’s Broader FDA History:
  • Aurobindo and its subsidiaries, including Aurolife, have faced FDA scrutiny at multiple facilities. For example:
    • In 2020, Aurolife’s Dayton, New Jersey facility received a Form 483 with nine observations and an Official Action Indicated (OAI) classification, indicating more serious concerns. Issues included water leaks and impurity concerns in active pharmaceutical ingredients (APIs).
    • In August 2024, Aurobindo’s Eugia unit in Hyderabad, India, received a warning letter following multiple Form 483s.
  • These incidents highlight recurring challenges with CGMP compliance, particularly in procedural and quality control areas, across Aurobindo’s global operations.

Implications

• Regulatory Risk: While the 11 observations are described as procedural, the number is relatively high, suggesting systemic issues in processes or documentation. If not addressed adequately, these could escalate to a warning letter or import alert, though Aurobindo’s proactive stance reduces this risk.
• Market and Investor Sentiment: Aurobindo’s stock may face short-term pressure due to the Form 483, as seen in past instances (e.g., a 1.64% share price drop after a 2023 Form 483). However, the company’s assurance of no material impact may mitigate significant financial fallout.
• Operational Continuity: The lack of data integrity or critical quality issues (e.g., sterility failures) supports Aurobindo’s claim that production and supply chains will remain unaffected.

Sources

• CNBC TV18, April 11, 2025: “Aurobindo Pharma’s Aurolife plant in North Carolina faces US FDA scrutiny, gets Form 483 with 11 observations.”
• Fierce Pharma, April 14, 2025: “Aurobindo gets Form 483 scolding from FDA at North Carolina inhaler plant.”
• NDTV Profit, April 11, 2025: “Aurobindo Pharma’s US Plant Gets 11 FDA Observations.”
• The Hindu, April 11, 2025: “Aurobindo Pharma arm’s North Carolina unit gets 11 U.S. FDA observations.”
• The Economic Times, April 11, 2025: “USFDA issues Form 483 with 11 observations to Raleigh plant of Aurobindo Pharma arm.”