FDA 483 - Impax Laboratories, LLC. - March 28, 2012

This FDA Form 483 document outlines several significant observations made during an inspection, indicating a failure to adhere to Good Manufacturing Practices (GMP) for drug products.

**Key Observations:**

1. **Non-conforming Product Handling:** Drug products that fail to meet established standards and specifications are not being rejected. This indicates a critical lapse in quality control and the potential for sub-standard products to enter the market.

2. **Inadequate Investigations:** Investigations into failures of a batch or its components to meet specifications are not being extended to other batches of the same drug product. This suggests a systemic issue where root causes are not being thoroughly identified and addressed across relevant production runs, potentially allowing recurring defects.

3. **Non-Adherence to Written Procedures (Sampling & Testing):** Written procedures for sampling and testing plans are not being followed for each drug product. This undermines the reliability and validity of quality control data.

4. **Non-Adherence to Written Procedures (Production & Process Control):** Written production and process control procedures are not being followed in the execution of production and process control functions. This indicates a lack of adherence to established manufacturing protocols, which can lead to inconsistent product quality.

5. **Failure to Document and Investigate Discrepancies:** There is a failure to document and investigate unexplained discrepancies that arise during manufacturing and Quality Control (QC) analytical testing, specifically referencing the issues detailed in Observations 1 to 4.