FDA Inspection
LNK International, Inc.LNK International, Inc. – FDA Inspection, Feb 8, 2019
Record Details
This FDA Inspection record concerns LNK International, Inc., with an inspection on February 8, 2019, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 7267ce47-4efa-47ae-ab0f-a32318c0a8f9
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1078694
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
- Enforcement
- Warning Letter
FDA Citations
3- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.198(b)(2)Written record of complaint to include findings, follow-up
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Other FDA inspections of LNK International, Inc.
16| Date | Classification | Office | Project area |
|---|---|---|---|
| August 27, 2026 | Not classified | New York District Office | |
| October 28, 2025 | VAI | New York District Office | Drug Quality Assurance |
| July 1, 2021 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 7, 2017 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| January 25, 2016 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
Other documents for LNK International, Inc.
- FDA Inspection 1288018 - 2026-08-27
- FDA Inspection 1281600 - 2025-10-28
- FDA Inspection 1145956 - 2021-07-01
- FDA Inspection 1007918 - 2017-03-07
- FDA Inspection 957377 - 2016-01-25
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