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

Source: https://www.keypedia.com/records/483/impax-laboratories-llc/bacb80ad-e9b7-4bae-a3d7-077a816b13df

> FDA 483 for Impax Laboratories, LLC. on March 28, 2012. Product: N/A. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Impax Laboratories, LLC.
- Inspection Date: 2012-03-28
- Office Name: San Francisco District Office
- Summary: 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.

## Related Documents

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- [CRL - Unknown Date](https://www.keypedia.com/records/crl/impax-laboratories-llc/c727e51f-f287-4aca-8cc2-634a540b66ff)

## Related Officers

- [Self-employed](https://www.keypedia.com/people/william-v-millar/867ce222-e0f0-44e0-a241-2d2fd5b024fc)
- [President](https://www.keypedia.com/people/peter-e-baker/c32eb848-de28-4725-80c9-ef8548d445bf)

Company: https://www.keypedia.com/companies/impax-laboratories-llc/7d8ef88a-fa0d-491d-b7f5-600a09806c0d

Office: https://www.keypedia.com/offices/san-francisco-district-office/6f838e9c-aae1-4665-9c46-a51d43be02df