FDA 483 - Aurobindo Pharma Ltd - April 18, 2017

This FDA Form 483 document outlines several significant observations regarding laboratory controls and the quality control unit at an unnamed facility.

**Violations and Observations:**

* **Laboratory Controls Deficiencies:** The facility's laboratory controls do not incorporate scientifically sound and appropriate sampling plans and test procedures. These procedures are crucial for ensuring that components and drug products consistently meet established standards for identity, strength, quality, and purity. * **Quality Control Unit Authority:** The quality control unit lacks the necessary authority to thoroughly investigate errors that have occurred during operations. This limitation compromises their ability to identify root causes and implement effective corrective actions. * **Unwritten/Unfollowed Procedures:** The responsibilities and procedures governing the quality control unit are not documented in writing or are not fully adhered to as required. This absence of formal, followed procedures can lead to inconsistencies and a lack of accountability. * **Undocumented Deviations:** Deviations from written test procedures are not being recorded and justified. This omission prevents proper tracking, evaluation, and resolution of non-conforming events. * **Unassessed Test Method Sensitivity:** The sensitivity of test methods has not been adequately assessed. Without this assessment, there is no assurance that the methods are capable of detecting impurities or variations at appropriate levels. * **Incomplete Laboratory Records:** Laboratory records do not contain complete data derived from all tests, examinations, and assays. Comprehensive data is essential for demonstrating compliance with established specifications and standards