# FDA 483 - Quotient Sciences - Philadelphia, LLC - October 27, 2023

Source: https://www.keypedia.com/records/483/quotient-sciences-philadelphia-llc/4c7f8416-3471-4b51-b5df-21ff7a7185b9

> FDA 483 for Quotient Sciences - Philadelphia, LLC on October 27, 2023. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Quotient Sciences - Philadelphia, LLC
- Inspection Date: 2023-10-27
- Product Type: Drugs
- Office Name: Philadelphia District Office
- Summary: On October 27, 2023, the FDA issued a Form 483 to Quotient Sciences, a manufacturer located at 3080 Mccann Farm Dr, Garnet Valley, PA. The inspection, conducted from October 20-27, 2023, identified two primary observations.

Observation 1 details issues with equipment design and qualification. Specifically, equipment proposed for commercial manufacturing, including a [REDACTED] Tank and [REDACTED] Mixer (ID #[REDACTED]) and a [REDACTED] Tablet Press (ID #[REDACTED]), was not installed onsite. Furthermore, the firm failed to perform representative Performance Qualification (PQ) studies for several pieces of equipment used in manufacturing [REDACTED]. IQ/OQ studies for [REDACTED] and [REDACTED] were run at a [REDACTED] and did not demonstrate operation at the target [REDACTED] setting of [REDACTED] or the operating range of [REDACTED] as specified in the Master Batch Record. PQ studies for the [REDACTED]™ (ID #[REDACTED]), [REDACTED] (ID #[REDACTED]), and [REDACTED] (ID #[REDACTED]) were also deemed inadequate, failing to demonstrate intended operation for commercial scale batch sizes. This observation is a repeat from a previous FDA 483 issued on August 1

## Related Documents

- [483 - 2022-08-16](https://www.keypedia.com/records/483/quotient-sciences-philadelphia-llc/8d2dd08a-44d4-4267-9356-233260aeb015)
- [EIR - 2022-08-16](https://www.keypedia.com/records/eir/quotient-sciences-philadelphia-llc/dfacca52-3581-4313-8c82-b611bd480b95)

## Related Officers

- [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