FDA Inspection
LNK International, Inc.LNK International, Inc. – FDA Inspection, Oct 28, 2025
Record Details
This FDA Inspection record concerns LNK International, Inc., with an inspection on October 28, 2025, issued by the New York District Office, covering human drugs.
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ID · da1d52eb-bee1-4999-9311-d4cdd0058292
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1281600
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
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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 | |
| July 1, 2021 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 8, 2019 | OAI | 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 1145956 - 2021-07-01
- FDA Inspection 1078694 - 2019-02-08
- FDA Inspection 1007918 - 2017-03-07
- FDA Inspection 957377 - 2016-01-25
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