# FDA 483 - Impax Laboratories, LLC. - May 04, 2016

Source: https://www.keypedia.com/records/483/impax-laboratories-llc/0919f2eb-531a-449f-a910-881850a471eb

> FDA 483 for Impax Laboratories, LLC. on May 04, 2016. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Impax Laboratories, LLC.
- Inspection Date: 2016-05-04
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West V
- Summary: Impax Laboratories, Inc. in Hayward, CA, was inspected regarding its manufacturing and post-marketing adverse drug experience processes. The inspection revealed significant deficiencies in equipment cleaning validation and monitoring, as well as a lack of adequate written procedures and record-keeping for adverse drug experience reporting and review. These issues indicate potential risks to drug product quality and patient safety.

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

## Related Officers

- [National Program Expert- Pharmacy Compounding](https://www.keypedia.com/people/lucila-b-nwatu/3d1c9670-8206-425c-bddd-32e395293042)
- [Chemist/Biologist](https://www.keypedia.com/people/elizabeth-juarez/7f839580-0a05-49d9-9ccf-dba72a540c85)
- [Stephanie A. Slater](https://www.keypedia.com/people/stephanie-a-slater/f356e65c-3398-4688-8b86-4dcd4b9ae83b)

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

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-v/0f4dd01e-8e8a-4336-9abe-ce8b3d309e8b