- Aurobindo Pharma's Unit 7 in Telangana received nine USFDA observations after inspection
- USFDA cited gaps in quality investigations, root cause analysis, and OOS result handling
- Manufacturing deviations and batch record documentation were found incomplete or inconsistent
Aurobindo Pharma has received nine observations from the US Food and Drug Administration (USFDA) following an inspection of its Unit 7 manufacturing facility in Jedcherla, Telangana, highlighting gaps in quality systems, documentation, and data integrity at a plant central to its US generics business.
Shares of Aurobindo Pharma Ltd fell in trade following the release of the observations.
Key Observations
Among the key observations, the USFDA noted that quality investigations were not sufficiently thorough, and root causes were not properly identified. Out-of-specification (OOS) results were closed without adequate scientific justification, raising concerns over analytical rigor.
High‑severity CGMP gaps were observed across facilities/equipment, production/data integrity, quality systems, training, and lab controls—the full stack. This mix (including cross‑contamination risk, microbial findings, and data integrity lapses) elevates the probability of a Warning Letter and/or import restrictions if remediation is not rapid and credible.
The regulator also found that manufacturing deviations were not properly assessed for their potential impact on product quality. Additionally, batch records contained incomplete or inconsistent documentation, pointing to gaps in manufacturing oversight and record-keeping.
Cleaning validation procedures were flagged for lacking adequate supporting data, while equipment maintenance records were also found to be improperly documented, raising questions about operational controls.
The USFDA further highlighted deficiencies in environmental monitoring in manufacturing areas, indicating gaps in ensuring controlled production conditions.
Non‑dedicated HVAC/HEPA & ductwork serving production areas had years of residue build‑up; HEPA surrounds and ducts showed significant deposits. Swab tests on ducts/filters found multiple drug substances well above cleaning limits—up to ~545× the acceptance limit on some locations (HPLC). Unknown peaks were also detected but not identified.
Bird droppings, dust layers, and microbial growth were observed inside filter housings/ducts; microbial testing indicated TNTC counts and presence/indications of organisms including Pseudomonas and E. coli. Preventive maintenance and QA oversight over the HVAC/HEPA system were inadequate (no periodic physical verification by QA; cleaning claims later retracted; lack of documented procedures for Type‑C cleaning of HEPA assemblies).
Data Integrity Concerns
Data integrity controls in laboratory systems were found to be weak, while access controls in computerized systems were not adequately restricted, increasing the risk of unauthorized data modification or integrity breaches.
Data integrity red flags (shared logins, backdating, deletion permissions, unverifiable copies) could drive deeper FDA scrutiny, lengthen remediation timelines, and raise compliance costs, with knock‑on impact to US sales if output or releases are slowed.
The site has already filed Field Alerts and executed a voluntary recall for certain tablets due to an impurity above AI limits, and stability data show additional lots trending borderline—potential for broader recall or market action.
While Form 483 observations do not immediately lead to regulatory sanctions, they require a detailed response outlining corrective and preventive actions.
The inspection, conducted between January 28 and February 10, resulted in a Form 483. The facility manufactures oral solid dosage forms, including tablets and capsules, and contributes nearly 20% of the company's US product portfolio, with over 150 ANDA filings supported by the site.
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