Company
United StatesSeaway Pharma Inc., Massena, NY – FDA Inspections
Inspection records and compliance data for Seaway Pharma Inc. in Massena, New York. 8 FDA inspections on record (4 OAI), 4 Form 483s, 1 warning letter, last inspected June 18, 2025.
Company Profile
This profile covers Seaway Pharma Inc. based in Massena, New York, United States.
FDA Inspection History
- FDA inspections
- 8
- OAI
- 4
- VAI
- 2
- NAI
- 2
- Form 483s
- 4
- Warning letters
- 1
First inspected April 17, 2015. Last inspected June 18, 2025.
Most cited issue areas
- Procedures not in writing, fully followed5 inspections
- Absence of Written Procedures3 inspections
- Cleaning SOPs/instructions3 inspections
FDA inspections (8)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| June 18, 2025 | OAI | Human Drugs · Drug Quality Assurance | 1272511 |
| July 25, 2024 | NAI | Foods & Cosmetics · Food Composition, Standards, Labeling and Econ | 1234892 |
| September 21, 2023 | OAI | Human Drugs · Drug Quality Assurance | 1220786 |
| September 15, 2021 | OAI | Human Drugs · Drug Quality Assurance | 1151771 |
| July 25, 2019 | VAI | Foods & Cosmetics · Food Composition, Standards, Labeling and Econ | 1097845 |
| December 10, 2018 | OAI | Human Drugs · Drug Quality Assurance | 1075781 |
| March 1, 2017 | NAI | Human Drugs · Drug Quality Assurance | 1003878 |
| April 17, 2015 | VAI | Human Drugs · Drug Quality Assurance | 925028 |
FDA documents
Form 483s (4)
- Form 483s · June 18, 2025
- Form 483s · July 24, 2024
- Form 483s · September 21, 2023
- Form 483s · September 15, 2021
Warning Letters (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Seaway Pharma Inc.
FEI Number
3012275336
Address
5 County Route 42, Massena, New York 13662, United States
Country
United States
ID: c01e07b5-654d-448f-aa7e-00617078e232