# FDA 483 - I3 PHARMACEUTICALS LLC - February 22, 2022

Source: https://www.keypedia.com/records/483/i3-pharmaceuticals-llc/49683585-7024-4621-8470-fe1abb46f124

> FDA 483 for I3 PHARMACEUTICALS LLC on February 22, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: I3 PHARMACEUTICALS LLC
- Inspection Date: 2022-02-22
- Product Type: drugs
- Office Name: Philadelphia District Office
- Summary: An FDA inspection of I3 PHARMACEUTICALS LLC in Warminster, PA, from February 7-22, 2022, revealed significant deficiencies in manufacturing and quality control. Observations included inadequate cleaning procedures and validation, insufficient environmental controls for temperature and humidity, and failures in quality assurance oversight. The firm also lacked thorough investigations into out-of-specification results and proper laboratory control mechanisms.

## Related Documents

- [483 - 2018-12-21](https://www.keypedia.com/records/483/i3-pharmaceuticals-llc/3df9f304-a8ab-4222-9976-0ea043b43e6f)
- [483 - 2023-03-03](https://www.keypedia.com/records/483/i3-pharmaceuticals-llc/e5e38dd5-3e21-46a5-afbe-803fdfbdfcce)

## Related Officers

- [Consumer Safety Officer](https://www.keypedia.com/people/daniel-j-min/e8d901f7-c604-48e6-a723-f191dc3cd28c)
- [Pharmacy Intern/Certified Pharmacy Technician](https://www.keypedia.com/people/david-a-oluwo/209d60bd-27d8-487b-8249-1c6e44fcc317)

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