FDA Inspection
LNK International, Inc.LNK International, Inc. – FDA Inspection, Jul 1, 2021
Record Details
This FDA Inspection record concerns LNK International, Inc., with an inspection on July 1, 2021, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- LNK International, Inc.
- Inspection Date
- July 1, 2021
- Product Type
- Drugs
View Company Profile
ID · f4fdc487-563e-4a3a-a9a2-2a968f47fc7d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1145956
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
5- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.198(a)Procedures to be written and followed
- 21 CFR 211.22(d)Procedures not in writing, fully followed
Full citation text and observation details available on the Dashboard.
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 |
| 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 1281600 - 2025-10-28
- FDA Inspection 1078694 - 2019-02-08
- FDA Inspection 1007918 - 2017-03-07
- FDA Inspection 957377 - 2016-01-25
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