# FDA 483 - PEL Healthcare LLC - April 24, 2018

Source: https://www.keypedia.com/records/483/pel-healthcare-llc/3d458a71-6c08-4fad-8377-38ed94068d16

> FDA 483 for PEL Healthcare LLC on April 24, 2018. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: PEL Healthcare LLC
- Inspection Date: 2018-04-24
- Product Type: drugs
- Office Name: Philadelphia District Office
- Summary: G&W PA Laboratories, LLC, a human drug manufacturer in Sellersville, PA, was cited for failing to thoroughly review unexplained discrepancies and out-of-specification results. The inspection revealed multiple instances of incomplete investigations into product impurities and stability issues. This indicates significant deficiencies in the firm's quality control and investigation processes.

## Related Documents

- [483 - 2023-01-13](https://www.keypedia.com/records/483/pel-healthcare-llc/e671146b-2f23-4e31-acb1-d4b2d2077111)

## Related Officers

- [Investigator](https://www.keypedia.com/people/anita-r-michael/b7699b1a-4157-477e-8226-2cfc906fc61d)

Company: https://www.keypedia.com/companies/pel-healthcare-llc/d3d3b397-8bab-4f88-af83-ce4568b55e00

Office: https://www.keypedia.com/offices/philadelphia-district-office/c5ec7398-b3d5-4125-9793-fb7b972578d8