FDA Inspection
Lyne Laboratories, Inc.Lyne Laboratories, Inc. – FDA Inspection, Jan 25, 2018
Record Details
This FDA Inspection record concerns Lyne Laboratories, Inc., with an inspection on January 25, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 4442e28e-c441-4696-9b59-028352c1ecdf
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1038819
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.67(b)Written procedures not established/followed
- 21 CFR 211.100(b)SOPs not followed / documented
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Other FDA inspections of Lyne Laboratories, Inc.
9| Date | Classification | Office | Project area |
|---|---|---|---|
| March 10, 2026 | VAI | New England District Office | Drug Quality Assurance |
| October 21, 2022 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 8, 2021 | NAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| September 7, 2017 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| August 17, 2016 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Lyne Laboratories, Inc.
- FDA Inspection 1306884 - 2026-03-10
- FDA Inspection 1182001 - 2022-10-21
- FDA Inspection 1152572 - 2021-09-08
- FDA Inspection 1026803 - 2017-09-07
- FDA Inspection 983497 - 2016-08-17
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