FDA Inspection
LNK International, Inc.LNK International, Inc. – FDA Inspection, Jan 30, 2015
Record Details
This FDA Inspection record concerns LNK International, Inc., with an inspection on January 30, 2015, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- LNK International, Inc.
- Inspection Date
- January 30, 2015
- Product Type
- Drugs
View Company Profile
ID · 5cd27e7b-9ea0-4e9d-b7c0-6c410e352c68
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 917528
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
5- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.198(b)(2)Complaint Investigation/Follow-Up Findings
- 21 CFR 211.101(b)Measured components for manufacturing
- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.67(b)Written procedures fail to include
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 |
| 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 |
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 1078694 - 2019-02-08
- FDA Inspection 1007918 - 2017-03-07
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