# FDA 483 - Impax Laboratories, LLC. - February 28, 2013

Source: https://www.keypedia.com/records/483/impax-laboratories-llc/190dfd4f-1b67-453f-861d-89bf458c18c7

> FDA 483 for Impax Laboratories, LLC. on February 28, 2013. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Impax Laboratories, LLC.
- Inspection Date: 2013-02-28
- Product Type: Drugs
- Office Name: San Francisco District Office
- Summary: This FDA Form 483 document details observations from an inspection, indicating several deficiencies in the facility's operations and quality systems.

**Test Methods and Quality Control:**
*   The accuracy, sensitivity, specificity, and reproducibility of test methods have not been established.
*   Non-suitable test methods are used for releasing finished drug products.
*   Test methods are not formally validated or determined acceptable prior to use in the QC laboratory.
*   Reports of analysis from component suppliers are accepted without validating the reliability of their analyses.

**Manufacturing Process and Controls:**
*   Control procedures are not established to validate manufacturing process performance, leading to variability in in-process material and drug product characteristics.
*   Inadequate controls over computer systems allow unauthorized changes to master production and control records.
*   Batch production and control records lack complete information.

**Documentation and Procedures:**
*   Written cleaning and maintenance procedures lack sufficient detail regarding methods, equipment, materials, disassembly/reassembly, and operational parameters.
*   Annual reports do not include a full description of manufacturing and control changes.
*   Written procedures for warehousing drug products are not followed.
*   Written procedures for annual product evaluations (including complaints, recalls, returns, and investigations) are not followed.

**Personnel and Storage:**
*   Employees involved in manufacturing and processing lack the required training and experience.
*   Drug products are not stored under appropriate humidity conditions, potentially affecting identity

## Related Documents

- [483 - 2012-03-28](https://www.keypedia.com/records/483/impax-laboratories-llc/bacb80ad-e9b7-4bae-a3d7-077a816b13df)
- [483 - 2016-05-04](https://www.keypedia.com/records/483/impax-laboratories-llc/780316ae-0bec-4aa8-9730-fe5c0b6f0846)
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## Related Officers

- [Chemist/Investigator - Pharmaceutical Quality](https://www.keypedia.com/people/walden-h-lee/18131eea-d1cb-47c4-af79-bea22d436031)
- [Chemit](https://www.keypedia.com/people/kim-l-thomas-cruse/1cba9ac7-c7b4-44e8-9a5b-274d8d9d2584)
- [ Assistant Country Director (USFDA India Office Drug Program)](https://www.keypedia.com/people/daniel-j-roberts/1e1836ac-8bca-4236-a267-33ee0456440c)

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