FDA Inspection
Haw Par Healthcare LimitedHaw Par Healthcare Limited – FDA Inspection, Mar 28, 2014
Record Details
This FDA Inspection record concerns Haw Par Healthcare Limited, with an inspection on March 28, 2014, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Haw Par Healthcare Limited
- Inspection Date
- March 28, 2014
- Product Type
- Drugs
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ID · a4929fc6-5c8a-4c1e-a677-237a11dd9819
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 873440
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
8- 21 CFR 211.137(b)Storage conditions
- 21 CFR 211.142(b)Storage under appropriate conditions
- 21 CFR 211.25(a)Training , Education , Experience overall
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.186(a)Written procedures followed
- 21 CFR 211.84(d)(2)Reports of Analysis (Components)
- 21 CFR 211.188(b)(11)Identification of Persons Performing Significant Steps
- 21 CFR 211.22(d)Procedures not in writing, fully followed
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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 |
| May 26, 2016 | 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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