# FDA 483 - Quotient Sciences - Philadelphia, LLC - August 16, 2022

Source: https://www.keypedia.com/records/483/quotient-sciences-philadelphia-llc/8d2dd08a-44d4-4267-9356-233260aeb015

> FDA 483 for Quotient Sciences - Philadelphia, LLC on August 16, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Quotient Sciences - Philadelphia, LLC
- Inspection Date: 2022-08-16
- Product Type: drugs
- Office Name: Philadelphia District Office
- Summary: An FDA inspection of Quotient Sciences in Garnet Valley, PA, revealed significant deficiencies in equipment qualification and cleaning validation practices. The firm failed to properly qualify manufacturing equipment through IQ/OQ/PQ studies and did not adequately investigate cleaning verification failures or validate cleaning procedures for equipment used in drug product manufacturing.

## Related Documents

- [EIR - 2022-08-16](https://www.keypedia.com/records/eir/quotient-sciences-philadelphia-llc/dfacca52-3581-4313-8c82-b611bd480b95)
- [483 - 2023-10-27](https://www.keypedia.com/records/483/quotient-sciences-philadelphia-llc/4c7f8416-3471-4b51-b5df-21ff7a7185b9)

## Related Officers

- [Consumer Safety Officer](https://www.keypedia.com/people/christina-k-theodorou/3c18d958-14de-4f25-9fbd-7358205155f7)
- [Consumer Safety Officer](https://www.keypedia.com/people/brandy-n-lepage/41e679e3-cc2a-4361-bf89-26acbd7deaf8)

Company: https://www.keypedia.com/companies/quotient-sciences-philadelphia-llc/89a4fd48-2064-499b-a555-ac6f8c924b41

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