FDA Inspection
Ultra Seal CorporationUltra Seal Corporation – FDA Inspection, Nov 19, 2021
Record Details
This FDA Inspection record concerns Ultra Seal Corporation, with an inspection on November 19, 2021, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Ultra Seal Corporation
- Inspection Date
- November 19, 2021
- Product Type
- Drugs
View Company Profile
ID · 646b6b1b-8fb2-4804-90b0-421383f1a299
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1157142
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
3- 21 CFR 211.22(a)Contract drug products--lack of responsibility
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.67(b)Written procedures not established/followed
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Ultra Seal Corporation
12| Date | Classification | Office | Project area |
|---|---|---|---|
| September 3, 2026 | VAI | New York District Office | Drug Quality Assurance |
| 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 |
Other documents for Ultra Seal Corporation
- FDA Inspection 1338618 - 2026-09-03
- FDA Inspection 1263334 - 2025-03-04
- FDA Inspection 1229281 - 2024-05-02
- FDA Inspection 1228761 - 2024-02-05
- FDA Inspection 1218129 - 2023-09-20
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.