# FDA 483 - I3 PHARMACEUTICALS LLC - May 22, 2026

Source: https://www.keypedia.com/records/483/i3-pharmaceuticals-llc/af8b41cd-2464-4cb5-ac06-7a1c7a3a071d

> FDA 483 for I3 PHARMACEUTICALS LLC on May 22, 2026. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: I3 PHARMACEUTICALS LLC
- Inspection Date: 2026-05-22
- Product Type: drugs
- Office Name: FDA District Office — Philadelphia, Pennsylvania
- Summary: I 3 Pharmaceuticals, LLC in Warminster, PA, was cited for two observations during an FDA inspection from May 18-22, 2026. The firm failed to properly design and maintain equipment, including an unqualified modification to a packaging line, and lacked written procedures for its use. Additionally, the quality control unit did not follow its own procedures, leading to delayed investigations of out-of-limit microbiological results and the release of affected drug product without proper review.

## 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)
- [483 - 2023-03-03](https://www.keypedia.com/records/483/i3-pharmaceuticals-llc/e5e38dd5-3e21-46a5-afbe-803fdfbdfcce)

## Related Officers

- [John D. McIntosh](https://www.keypedia.com/people/john-d-mcintosh/063cac5b-0933-4ecf-a9fb-835dd5d25ef2)
- [issuing_officer](https://www.keypedia.com/people/emily-a-walters/e80b3581-ffba-4244-9030-b6c9496da932)

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

Office: https://www.keypedia.com/offices/fda-district-office-philadelphia-pennsylvania/e70a6e70-40b2-49e4-8360-c3db36c4d2a0