FDA Inspection
Haw Par Healthcare LimitedHaw Par Healthcare Limited – FDA Inspection, May 26, 2016
Record Details
This FDA Inspection record concerns Haw Par Healthcare Limited, with an inspection on May 26, 2016, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Haw Par Healthcare Limited
- Inspection Date
- May 26, 2016
- Product Type
- Drugs
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ID · 4dbfc50e-d93c-4c99-baf1-27eddc91771b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 974315
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
6- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.125(a)Strict control not exercised over labeling issued
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.160(b)(4)Calibration - at intervals, written program, remedial action
- 21 CFR 211.56(c)Written procedures lacking for use of pesticides etc.
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Other FDA inspections of Haw Par Healthcare Limited
5| Date | Classification | Office | Project area |
|---|---|---|---|
| September 27, 2024 | VAI | Office of Inspections and Investigations | Drug Quality Assurance |
| 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 |
| 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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