# FDA 483 - I3 PHARMACEUTICALS LLC - March 03, 2023

Source: https://www.keypedia.com/records/483/i3-pharmaceuticals-llc/e5e38dd5-3e21-46a5-afbe-803fdfbdfcce

> FDA 483 for I3 PHARMACEUTICALS LLC on March 03, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: I3 PHARMACEUTICALS LLC
- Inspection Date: 2023-03-03
- Product Type: drugs
- Office Name: Philadelphia District Office
- Summary: I3 Pharmaceuticals LLC, a drug manufacturer in Warminster, PA, received two observations during an FDA inspection. The firm was cited for deficiencies in equipment qualification, specifically regarding drying times and inlet airflow ranges for manufacturing processes. Additionally, the inspection found inadequate written procedures for equipment cleaning and maintenance, including issues with the dirty hold time study.

## Related Documents

- [483 - 2018-12-21](https://www.keypedia.com/records/483/i3-pharmaceuticals-llc/3df9f304-a8ab-4222-9976-0ea043b43e6f)
- [483 - 2022-02-22](https://www.keypedia.com/records/483/i3-pharmaceuticals-llc/49683585-7024-4621-8470-fe1abb46f124)

## Related Officers

- [Amit Kokate](https://www.keypedia.com/people/amit-kokate/3c764e30-3a6f-4496-840a-30b678c0b3b8)
- [Investigator](https://www.keypedia.com/people/janet-a-rajan/95741927-9a4d-422b-bd51-01783d962cbe)
- [Consumer Safety Officer](https://www.keypedia.com/people/daniel-j-min/e8d901f7-c604-48e6-a723-f191dc3cd28c)

Company: https://www.keypedia.com/companies/i3-pharmaceuticals-llc/020702e4-1539-47b8-87d9-725035cecbfe

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