FDA Inspection
LNK International, Inc.LNK International, Inc. – FDA Inspection, Jan 14, 2010
Record Details
This FDA Inspection record concerns LNK International, Inc., with an inspection on January 14, 2010, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- LNK International, Inc.
- Inspection Date
- January 14, 2010
- Product Type
- Drugs
View Company Profile
ID · 368c24ec-7140-4557-9b9f-88ea31bdaf75
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 637013
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
7- 21 CFR 314.81(b)(1)(ii)Failure to meet specifications
- 21 CFR 211.84(a)Components withheld from use pending release
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.122(b)Labeling and packaging improperly approved/released
- 21 CFR 211.22(a)Authority lacking to review records, investigate errors
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
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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 |
| 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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