FDA Inspection
OLIC (Thailand) LimitedOLIC (Thailand) Limited – FDA Inspection, Mar 15, 2023
Record Details
This FDA Inspection record concerns OLIC (Thailand) Limited, with an inspection on March 15, 2023, issued by the Office of Inspections and Investigations.
- Company
- OLIC (Thailand) Limited
- Inspection Date
- March 15, 2023
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ID · 9b262ab5-99ba-49ad-bc7c-d6f9887706cd
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1199793
- FDA center
- Human Drugs
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.130(b)Unlabeled filled containers controls
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Other FDA inspections of OLIC (Thailand) Limited
4| Date | Classification | Office | Project area |
|---|---|---|---|
| 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 |
| November 18, 2016 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| May 2, 2014 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for OLIC (Thailand) Limited
- FDA Inspection 1192293 - 2022-10-28
- FDA Inspection 1079358 - 2018-11-22
- FDA Inspection 998197 - 2016-11-18
- FDA Inspection 880811 - 2014-05-02
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