FDA Inspection
Seaway Pharma Inc.Seaway Pharma Inc. – FDA Inspection, Jun 18, 2025
Record Details
This FDA Inspection record concerns Seaway Pharma Inc., with an inspection on June 18, 2025, issued by the New York District Office, covering human drugs.
View Company Profile
ID · ed914a53-d246-4b5f-8547-16c7b4be72d3
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1272511
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
11- 21 CFR 211.56(a)Sanitation--buildings not clean, free of infestation
- 21 CFR 211.165(b)Microbiological testing
- 21 CFR 211.160(a)Following/documenting laboratory controls
- 21 CFR 211.194(a)(4)Complete Test Data
- 21 CFR 211.67(b)(3)Cleaning SOPs/instructions
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.84(d)(1)Identity Testing of Each Component
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.166(a)Written program not followed
Showing 10 of 11 citations.
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Seaway Pharma Inc.
7| Date | Classification | Office | Project area |
|---|---|---|---|
| July 25, 2024 | NAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| September 21, 2023 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 15, 2021 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| July 25, 2019 | VAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| December 10, 2018 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Seaway Pharma Inc.
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.