FDA Inspection
OLIC (Thailand) LimitedOLIC (Thailand) Limited – FDA Inspection, Nov 18, 2016
Record Details
This FDA Inspection record concerns OLIC (Thailand) Limited, with an inspection on November 18, 2016, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · a579e9b2-45ee-49b9-8f58-1bda6377eea6
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 998197
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.192Quality control unit review of records
- 21 CFR 211.160(a)Following/documenting laboratory controls
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.170(b)Annual visual exams of drug products
- 21 CFR 211.192Written record of investigation incomplete
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Other FDA inspections of OLIC (Thailand) Limited
4| Date | Classification | Office | Project area |
|---|---|---|---|
| March 15, 2023 | VAI | Office of Inspections and Investigations | |
| October 28, 2022 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| November 22, 2018 | NAI | Center for Drug Evaluation and Research | Over-the-Counter Drug Evaluation |
| May 2, 2014 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for OLIC (Thailand) Limited
- FDA Inspection 1199793 - 2023-03-15
- FDA Inspection 1192293 - 2022-10-28
- FDA Inspection 1079358 - 2018-11-22
- FDA Inspection 880811 - 2014-05-02
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