FDA Inspection
Ultra Seal CorporationUltra Seal Corporation – FDA Inspection, Sep 3, 2026
Record Details
This FDA Inspection record concerns Ultra Seal Corporation, with an inspection on September 3, 2026, issued by the New York District Office, covering human drugs.
- Office
- New York District Office
- People
- Daniel T. Lee (Company Rep)
- Easton J. Reagan (Issuing Officer)
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ID · 1c499379-feb6-4045-ae46-b2ca42a28530
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1338618
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 211.67(b)(2)Cleaning SOPs/schedules
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Other FDA inspections of Ultra Seal Corporation
12| Date | Classification | Office | Project area |
|---|---|---|---|
| March 4, 2025 | NAI | Center for Tobacco Products | Tobacco Post-Market Activities |
| May 2, 2024 | NAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| February 5, 2024 | NAI | Center for Tobacco Products | Tobacco Post-Market Activities |
| September 20, 2023 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| November 19, 2021 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Ultra Seal Corporation
- FDA Inspection 1263334 - 2025-03-04
- FDA Inspection 1229281 - 2024-05-02
- FDA Inspection 1228761 - 2024-02-05
- FDA Inspection 1218129 - 2023-09-20
- FDA Inspection 1157142 - 2021-11-19
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