# FDA 483 - Seaway Pharma Inc. - July 24, 2024

Source: https://www.keypedia.com/records/483/seaway-pharma-inc/c9172b7d-5459-4623-af9a-98a86d9be5fd

> FDA 483 for Seaway Pharma Inc. on July 24, 2024. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Seaway Pharma Inc.
- Inspection Date: 2024-07-24
- Product Type: drugs
- Office Name: New York District Office
- Summary: An FDA inspection of Seaway Pharma Inc. in Massena, NY, revealed a significant issue with the physical plant's plumbing system. The observation noted a cross-connection risk between waste/sewage lines and water used for manufacturing dietary supplements, cleaning, or hand-washing facilities. This indicates a potential for insanitary conditions impacting product quality and safety.

## Related Documents

- [483 - 2021-09-15](https://www.keypedia.com/records/483/seaway-pharma-inc/8c5dc376-f080-400d-b522-731b4f82a885)
- [483 - 2023-09-21](https://www.keypedia.com/records/483/seaway-pharma-inc/f26f8c30-aba7-42cf-90d5-a07bc65c38fc)
- [483 - 2025-06-18](https://www.keypedia.com/records/483/seaway-pharma-inc/8a7c810d-9db1-43b3-8e6d-2b32a0a584a4)
- [WARNING_LETTER - 2025-06-18](https://www.keypedia.com/records/warning_letter/seaway-pharma-inc/9b5afeb8-99bf-42a5-8163-7cd92e201cf0)

## Related Officers

- [Lirissia Mccoy](https://www.keypedia.com/people/lirissia-mccoy/f0b10a82-f4e5-4182-bbee-1fef1b7fa1ae)

Company: https://www.keypedia.com/companies/seaway-pharma-inc/c01e07b5-654d-448f-aa7e-00617078e232

Office: https://www.keypedia.com/offices/new-york-district-office/9fa3d265-16ca-438d-8a6e-b47f60dc260d