Aurobindo Pharma Limited – FDA Warning Letter, Feb 9, 2019

The FDA issued a Warning Letter to Aurobindo Pharma Limited (APL), Unit XI, following an inspection from February 4-9, 2019, which revealed significant deviations from current Good Manufacturing Practice (CGMP) for active pharmaceutical ingredients (API). This renders their API adulterated under 21 U.S.C. 351(a)(2)(B).

Key violations include: 1. **Failure to extend investigations:** The firm's investigation into (b)(4) impurities in (b)(4) and (b)(4) API was deficient, failing to evaluate all potential sources like key starting materials and solvents. After EDQM informed them of (b)(4) contamination, APL found (b)(4)% of batches contaminated, attributing it to a contract manufacturer's inadequate cleaning. APL's response was inadequate as it did not address quality oversight of contractors. 2. **Failure to ensure equipment quality:** Rust was observed on over (b)(4)% of a (b)(4) used for (b)(4) API. The investigation was insufficient, and corrective actions did not ensure other drug manufacturing equipment had adequate contact surfaces. 3. **Failure to comply with submission requirements:** APL failed to submit supplemental (b)(4) to report specification changes in DMF (b)(4), as required by 21 CFR 314.97(a). Non-