FDA Inspection
Haw Par Healthcare LimitedHaw Par Healthcare Limited – FDA Inspection, Sep 27, 2024
Record Details
This FDA Inspection record concerns Haw Par Healthcare Limited, with an inspection on September 27, 2024, issued by the Office of Inspections and Investigations, covering human drugs.
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ID · f16ba831-da4c-42d2-82c1-0e95993cc687
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1250188
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
7- 21 CFR 211.198(b)(3)Reason for Not Conducting Complaint Investigation
- 21 CFR 211.165(b)Microbiological testing
- 21 CFR 211.80(d)Status of Each Lot Identified
- 21 CFR 211.130(c)Lot or control number assigned
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.111Establishment of time limitations
- 21 CFR 211.80(a)Written Procedures Not Followed
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Other FDA inspections of Haw Par Healthcare Limited
5| Date | Classification | Office | Project area |
|---|---|---|---|
| August 19, 2022 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 1, 2019 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| May 26, 2016 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 28, 2014 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| October 29, 2009 | OAI | Center for Drug Evaluation and Research | Postmarket Surv. and Epidemiology |
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